46 Sealing Jobs

Hi, Greetings from Adecco , A Leading Manpower Consulting Company!!! We have been retained by Leading Pharmaceuticals Company in Ahmedabad for their Manpower Requirements. We have an following Openings as of now. 1) Operators 2) Technician 3) Aseptic Operator 4) Aseptic Officer Education: ITI/Diploma/Bsc/Msc/B Pharma / M Pharma Experience: 3 to 10 Years. Interested candidates please connect on below contact details. Mayuri Shah Senior Consultant (Life Sciences & Pharmaceutical) Mail id : mayuri.shah@adecco.com M-(whatsapp) 7984968546/ 9714846221 Adecco Group India

Role & responsibilities Role - Aseptic Area Manufacturing Skill operation and supervising of filling machine, sealing machine , ALUS operation , storage vessel operation and cleaning Qualification B. Pharm/M. Pharm Category – Staff

Role & responsibilities For operator Role - Aseptic Area Manufacturing Skill - operation of filling machine (vial or sealing machine) , ALUS operation , storage vessel operation and cleaning Qualification Diploma Eng/ITI

You should have a minimum of 5-10 years of experience in physical work at a plant if you hold a B.E degree, with a technical background in Automotive Paint Process, Manufacturing, or Engineering. Your experience should include working in at least one process line, either in 4-wheel or 2-wheel vehicles, focusing on Pre-Treatment, Sealing, Topcoat, and Bumper paint processes. It is essential that you are able to identify and address quality issues within your assigned process line and comprehend the impact of these issues on the overall Paint Process. Moreover, you should possess a basic understanding of Paint shop Equipment installation and commissioning, as well as familiarity with Basic Safety procedures, Chemical usage, Material Handling & Conveyors systems, and Paint Quality management systems. This knowledge will be crucial in ensuring the smooth operation and quality output of the Paint Process.,

Interview for SVP & Injectable Pharma Formulation Plant in Bharuch on Company / Permanent Payroll Experience: 2 to 6 Yrs CTC: As per industry Work Location: Dahej Send CV on sdpbharuch@gmail.com with Subject: SVP Bharuch & Call 7600033423 Free Job Required Candidate profile Autoclave Operator Granulation Operator Mixing Operator Grinding Operator Cartonator Operator Washing Tunnel Operator Ampoule Filling Operator Vial Filling Operator Vial Sealing Operator Lyo Operator

Interview for SVP & Injectible Pharma Formulation Plant in Bharuch on Company / Permanent Payroll Experience: 2 to 6 Yrs CTC: As per industry Work Location: Dahej Send CV on sdpbharuch@gmail.com with Subject: SVP Bharuch & Call 7600033423 Free Job Required Candidate profile Autoclave Operator Granulation Operator Mixing Operator Grinding Operator Cartonator Operator Washing Tunnel Operator Ampoule Filling Operator Vial Filling Operator Vial Sealing Operator Lyo Operator

We are looking for a Technical Sales Associate to join our dynamic team. In this role, you will be responsible for executing sales strategies, developing strong relationships with customers, and providing technical support. You will have the opportunity to contribute to the growth of our new brand and make a positive impact in the industrial sector. Key Responsibilities Develop and execute effective sales strategies to increase market share for our new brand. Build and maintain strong customer relationships and generate new business leads. Provide technical expertise to customers, including product recommendations, troubleshooting, and training. Prepare and deliver sales presentations , proposals, and product demonstrations. Stay updated on industry trends, market developments , and competitor activities . Desired Candidate Profile Sales experience in industrial equipment and materials (e.g., gaskets, sealing products, bearings, valves, pumps, sensors, industrial rubber, plastics, etc.). Willingness to travel for sales pitches and client meetings. Proven ability to manage B2B sales and customer relationships effectively. Required Qualifications Bachelors Degree 2+ years of experience in industrial sales or related fields. Key Skills Industrial Sales B2B Sales Customer Relationship Management Technical Sales Support Product Demonstrations Compensation CTC : 4 to 6 LPA Location Hybrid (Kolkata) Candidate Location : East and North-East India

The ideal candidate for this role will be responsible for updating self-hygiene practices and ensuring adherence to standard operating procedures within the sterile manufacturing department. You will be in charge of preparing, reviewing, revising, controlling, and implementing SOPs, master documents of production, protocols, and reports. Additionally, you will manage documentations like BMRs, BPRs, and master SOPs, as well as handle change control, deviations, CAPA, investigations, and various manufacturing operations such as filling, sealing, labeling, and packing. Furthermore, you will be required to create production planning on a monthly and daily basis, prepare daily production reports, ensure equipment validation and calibration, and maintain compliance with cGMP, GDP, and departmental discipline. Monitoring manufacturing records, providing training to subordinates, technicians, and operators, and executing tasks as instructed by the HOD are also part of your responsibilities. Moreover, attending training sessions as per schedule, maintaining facility compliance, and ensuring the area is inspection-ready are crucial aspects of the job. Proficiency in equipment operation, cleaning, dispensing, sterilization, filtration, process validation, troubleshooting, and people management will be valuable skills in this role. The preferred educational background for this position is a B.Pharma or M.Pharma degree, along with a total experience of 15 to 18 years in a sterile manufacturing plant.,

Are you passionate about automotive design and engineering excellence We are seeking a BIW Sealing and Glasses Design Lead to become part of our dynamic team and lead innovation in vehicle architecture! With 8 to 15 years of experience in Sealing and Glasses Design & Development at an Automobile OEM, you will collaborate with cross-functional teams, including Body-in-White (BIW), Door Trim, and Vehicle Integration, to ensure sealing and glass system compatibility and performance. Your expertise should include hands-on experience in the automobile domain, specifically working on BIW closure systems such as Door, Tailgate, and Hood, along with their subsystem designs. In this role, you will interface with suppliers to oversee glass tooling, lamination, tempering, and encapsulation processes. Your responsibilities will also involve ensuring compliance with regulatory and internal standards for water tightness, air leakage, dust ingress, and NVH. Proficiency in EPDM, TPV, TPE materials, extrusion/molding processes, and optical distortion assessments is essential. Familiarity with Catia and PLM software like Teamcenter, as well as knowledge of engineering and system documents such as DFMEA, DVP, and DFA, are required. Candidates should possess a strong technical understanding of automotive sheet metal parts, manufacturing, and assembly processes. Additionally, the ability to prepare and deliver presentations of concepts/master sections, conduct tolerance stack-up, and have knowledge of GD&T will be advantageous. Hands-on experience in part development and supplier interaction is a plus. The ideal candidate will hold a B.E. degree in Mechanical/Automobile Engineering with 8-15 years of experience. If you are ready to take ownership of high-impact design programs and contribute to shaping the future of mobility, we would love to connect with you! To apply or refer someone for this exciting opportunity, please send an email to Tanvi.More@hindujatech.com. Join us in this journey of innovation and excellence in the automotive industry! #Hiring #BIWDesign #BonnetDesign #AutomotiveJobs #DesignLead #MechanicalEngineering #Mobility #CADDesign #CareerOpportunity Feel free to let us know if you require further customization based on a specific company, region, or level of experience.,

A reputed company in Qatar is urgently hiring Ductmen for HVAC installations. As a Ductman, your responsibilities will include installing and assembling GI and PI ductwork for HVAC systems. You will be required to measure, cut, and join ducts using appropriate hand and power tools, ensuring airtight connections and correct duct alignments. It will be essential for you to interpret drawings, layouts, and site instructions accurately. Additionally, you will assist in the insulation and sealing of duct systems while maintaining cleanliness and safety standards at work sites. The ideal candidate for this position should have a minimum of 3-5 years of experience either in India or the Gulf region. You must be physically fit, hardworking, and ready for immediate deployment. Skills required for this role include expertise in GI and HVAC systems, joining ducts, interpreting instructions, installing HVAC systems, adhering to safety standards, cutting and fitting ducts, interpreting drawings, ensuring connections, ductwork assembly, insulation, usage of power and hand tools, and measuring accurately. If you meet the above requirements and are keen on working in Qatar, this could be the perfect opportunity for you.,

Role & responsibilities Responsibility 1- Ensure high level of Customer Satisfaction, by constant interaction with Customers as well as with HO, understanding the requirements of both ends. Responsibility 2 Hold initial level of technical discussions with Customers and conveying the same to AE team, as required. Need to grow business with existing Customers, taking major share of business from each of them. Responsibility 3 Should be aware of each Customers total Seal potential and also the Competitor activities with each of them. To develop strategy on how to grow the business with the Customers and also how to beat the Competition. . Responsibility 4 Identify new Customers and New Projects, to accelerate the growth of Triada. Ensure that the projects are pushed for SOP asap. Responsibility 5 Feeding HO/Strategic Marketing about market trends as well as Competitor activities in his area of responsibility. Responsibility 6 Ensure a good brand image for Triada in front of Customers, Competitors and also in the industry/market. Responsibility 7 Appropriate pricing of Products and Services, to ensure profitability & sustainability of the Company. Need to negotiate with Customers for a win-win situation, so that both ends are satisfied being in the business relationship. Responsibility 8 Ensure a good AR status, based on the business and credit worthiness of each customer. Daily Sales Outstanding (DSO) to be maintained for his area of responsibility/Customers, as agreed with Management. Preferred candidate profile Must-Haves Minimum 3-5 years of experience in Sales activities, handling OEMs only. Must have been involved in Customer meetings/interactions . Good reading habit, preferably technical Hands-on experience in a shop floor/design environment Must have made Customer presentations or Seminars. Must have travelled in his intended area, covering OEM Customers. Good Sales Record in his previous assignment. Good to have Experience in hydraulic aggregate manufacturing/ design. CHENNAI-JOB LOCATION: REMOTE DELHI/NCR-REMOTE BANGALORE-WORK FROM OFFICE

Walk In Drive For Production Injectables In Formulation Division @ RK Puram Department:- Production Injectables Qualification :- B Tech | B Sc | B Pharmacy | M Sc | M Pharmacy Experience :- 2-4 Years Skills :- Documentation :- BMR & Process validation protocol document preparation & Review | SOP Preparation & Review | QMS Elements | Production & Audit Compliance Qualification :- ITI | Diploma Experience :- 2-4 Years Skills :-Filling Operator Qualification :- ITI | Diploma | B Sc |B Tech Experience :- 10-12 Years Skills :- Senior Filling Operators :- ALUS | Vial filling | Stoppering | Sealing Machine | PFS Division :- Formulation Interview Date:19-07-2025 (Saturday) Interview Time :- 9.00AM TO 2.00PM Work Location:- Unit-V, RK Puram Venue Location :- MSNF Unit-V, Rk Puram 25GX+XHX, Solipur, Telangana 509216 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Role & responsibilities 1. Follow the instruction & procedure given in Entry- Exit SOP (Standard Operating Procedure) of Grade C, decartoning area and Grade B’ area. 2. Responsible a procedure for proper functioning or behaviour in aseptic area. 3. Follow the personnel hygiene practices in factory premises. 4. Follow the GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) as per given in SOP. 5. Responsible for monitoring of temperature, relative humidity and differential pressure. 6. Responsible for monitoring of differential pressure of laminar air flow units and pass boxes. 7. Responsible for handling of material movement in production area. 8. Responsible for maintain the document as per GDP and area as per cGMP. 9. Responsible for to maintain day to day records. 10. Responsible for training to new joining chemist, workers and operators for their respective job. 11. Carrying out the line clearance before starting the operation. 12. Responsible for planning of manufacturing as per availability of RM and PM. 13. Responsible for supervision of preparation and filtration of cleaning/ disinfectant solutions and fogging solutions. 14. Responsible for supervision of equipments/ machines and utility readyness before batch manufacturing. 15.Responsible for supervision of operation and cleaning of steam sterilizer, compounding vessel and holding vessel, vial washing machine, sterilization and depyrogenation tunnel, washing and drying and wrapping of garments and pass box and laminar air flow. 16. Responsible for supervision of handling of filters, filter integrity testing apparatus, silicon tubing, decartoning area and hose pipes and cleaning and wrapping of glassware, auxiliary items and machine parts. 17. Responsible for supervision of operation of pH meter and stirrer. 18. Responsible for supervision of aseptic process stimulation, post media fill cleaning and sanitization of machine and area as per procedure. 19. Responsible for destruction of media filled vials. 20. Responsible for supervision for general area cleaning and sanitization of grade ‘C’ and ‘D’ area and fogging activity of respective area. 21. Responsible for verification of load cell. 22. Responsible for verifying the handling of waste generated in production area. 23. Responsible for non viable particle count (online and offline) monitoring. 24. Recording the operation and cleaning details in batch manufacturing record and equipment uses log book. 25. Responsible for handling of equipment like homogenizer, rota evaporator, magnetic stirrer, ultrsonicator, pH meter and fogger. 26. Follow the procedure for dispensing room and responsible for RM and PPM dispensing and additional materials issuance. 27. Responsible for all data entry for batch manufacturing process in pharmacloud system. 28. Responsible for audit preparation and execution. 29.To undergo periodic medical checkup arranged by the company. 30.Performing the task assigned by the supervisor. 31. Reporting regarding unsafe act/ unsafe condition/ accident/ incident to supervisors. Preferred candidate profile Candidate Should have Exposure of Pharma Injectable Plant. Candidate Should well familiar with Pharma Guidelines. Candidate should have good Verbal and Written Communication Willing to Relocate in Navsari, Gujarat, Willing to Work in a Shift.

Walk In Drive For Production Injectables In Formulation Division @Bollaram Department:- Production Injectables Qualification :- Diploma | ITI | B Tech | B Pharmacy | BSc Experience :- 2 to 4 Years Skills :- Operators:- Filling | Sealing | Lyophilization Division :- Formulation Interview Date:19-07-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:-MSNF Unit-I, Bollaram Venue Location :- Plot No- 42, Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana 502325 Contact No:- 040-304338787 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

You should possess 5-10 years of experience in a physical plant setting if you hold a B.E. degree, with a technical background in Automotive Paint Process, Manufacturing, or Engineering. It is essential to have experience in at least one process line, such as 4Wheel or 2Wheel, specifically in Pre-Treatment, Sealing, Topcoat, and Bumper paint processes. You must be capable of identifying and addressing quality issues within your process line and understand how these issues impact the overall Paint Process. Additionally, you should have a basic understanding of Paint shop Equipment installation & commissioning, Basic Safety procedures, Chemical usage, Material Handling & Conveyors systems, and Paint Quality management systems.,

Experience: 2 to 10 years of sterile area / injectables Manufacturing experience in a reputed organization Technical knowledge: -Good Technical knowledge in oRABS-Vial filling line and practical experience in handling the injectables manufacturing Equipment. -Worked in USFDA and EMA regulatory approved companies -Excellent quality oriented and result oriented attitude -Good experience in cGMP and GDP

Role & responsibilities For Production : Having Injectable Experience of Shop floor activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions (Handling of Homogenizer, Netzsch Mill/Bead Mill and Single use Systems) filtration, Lyophilizes. Having Injectable Experience of Shop floor supervising activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions (Handling of Homogenizer, Netzsch Mill/Bead Mill and Single use Systems) filtration, Lyophilizes. Operations and Training and QMS. For Quality Assurance : Having Injectable Experience of QMS, Audit & Compliance, IPQA, AQA (Microbiology), CSV Validations

Only from Pharmaceutical - Injectables candidate required Role & responsibilities Operation of filling machine, sealing machine , ALUS operation , storage vessel operation and cleaning Experience of operating Glass Vial filling machine / Autoclave / Sealing machine Interested candidates can apply on " hemin.darji@adecco.com" or call on 7567844566

We are hiring for the role of Production Supervisor Job Description / Responsibilities: Supervise day-to-day bottling, weighing, sealing, and labelling of fertilizer products. Ensure adherence to production schedules and packaging specifications. Monitor equipment performance and coordinate with the maintenance team for timely repairs. Maintain inventory of packaging materials (bags, bottles, labels, etc.). Ensure compliance with FCO norms, safety standards, and SOPs during plant operations. Train and guide machine operators on equipment handling, hygiene, and safety protocols. Maintain shift-wise production logs, downtime records, and quality inspection checklists. Coordinate with warehouse and dispatch teams to ensure smooth material flow. Implement 5S, TPM, and continuous improvement practices on the shop floor. Support internal and external audits, inspections, and quality certifications. Desired Candidate Profile: Prior experience in a chemical/fertilizer plant bottling or packaging operations is preferred. Strong knowledge of packaging machinery and safety protocols. Ability to manage shift teams and ensure production targets are met. Hands-on experience with plant documentation and compliance is a plus. Good communication skills and team management abilities.

WALK-IN DRIVE @ INDORE HETERO PHARMACEUTICALS Work Location: Hyderabad Interview Date: 06th July 2025 (Sunday) Timings: 9:00 a.m. to 4:00 p.m. Venue: Kyriad Hotel Indore, Plot No. 34-35, FF Scheme No. 54, Opposite Meghdoot Garden, Vijay Nagar, Indore, MP 452010 We’re hiring passionate professionals in the following departments: Production (OSD & Injectable) Quality Control (OSD) QA (Injectable) Eligibility: ITI / Diploma / B.Sc / B.Pharm / M.Sc / M.Pharm Experience: 2–9 Years Designations: Operator / Officer / Executive / Sr. Executive Areas of Work: Compression, Granulation, Inspection, Vial Washing, Visual Inspection, HPLC, GC, QMS, Compliance & more. Please carry: Updated Resume Education Certificates Last 3 Months’ Payslips Latest CTC Details Aadhar/PAN For queries: Prashanthkumar.v@hetero.com Contact: 9010203989 / 8555912639

Hi, Greetings from Adecco , A Leading Manpower Consulting Company!!! We have been retained by Leading Pharmaceuticals Company in Ahmedabad for their Manpower Requirements. We have an following Openings as of now. 1) Blister Operator 2) Blister Officer 3) Aseptic Operator 4) Aseptic Officer Education: ITI/Diploma/Bsc/Msc/B Pharma / M Pharma Experience: 3 to 10 Years. Interested candidates please connect on below contact details. Mayuri Shah Senior Consultant (Life Sciences & Pharmaceutical) M-(whatsapp) 7984968546/ 9714846221 Adecco Group India

Dear Aspirant , Greetings From Eugia Pharma Specialties , Unit ..! We glad to inform you all that we planned Walk In Interviews for below vacancies in our Manufacturing unit. Department - Production (Injectable) Qualification - M. Pharmacy / B. Pharmacy / M. Sc /B Sc / Diploma / ITI Designation - Sr. Executive / Executive/ Operators Experience - 2Yrs to 8 yr. Skills - Vial Filling/ Sealing / Autoclave / Lyo and etc Work Location : Eugia Unit -3, Pashamylaram Walk In Details: Date : 29.06.2025 Time : 09 AM - 02 PM Venue : Aurobindo Pharma Limited - Unit - 3 Sy. No. 313, Bachupally, Hyderabad, Telangana 500090 Google Map : https://maps.app.goo.gl/qoL8vZ6EwDm5GcWb8 Contact : Mr Prabhakar / Ms Rama

POSITION: FILLING OPERATOR (entry level) runs machines that fill sterile medicines Production of sterile injectable products like vials, ampoules, cartridges, and pre-filled syringes (PFS). COMPANY: OneSource CDMO Known for sterile injectables, prefilled syringes, autoinjectors, and soft gel capsules. Department: production, manufacturing, formulation Aseptic Filling Operations: Operate machines inside cleanrooms or isolators to fill sterile drug products without contamination. Machine Setup & Maintenance: Set up, calibrate, clean, and dismantle equipment like vial filling machines, lyophilizers, and sterilizers, cartridge filling/washing, Ampoule filling Visual Inspection & Leak Testing: Check for particulate matter, proper sealing, and container integrity.

Role & responsibilities Job summary We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule. " Roles & Responsibilities Perform filling, washing, sterilization operations as per the day plan, executing batch production records. Participate in filling area line clearance activities and perform machine cleaning operations. Handle material dispensing and issuance from the warehouse. Issue discrepancies, work with cross-functional departments to close discrepancies, and implement appropriate corrective actions. Compliance with GMP, safety standards, and SOPs (Standard Operating Procedure) for designated manufacturing equipment. Maintain records in machine operation log books. Maintain manufacturing equipment to ensure correct functionality and calibration compliance. Actively engage in validation and qualification activities for all manufacturing area machines. Promote safety awareness and improvements, engage in continuous improvement activities, and adhere to the company's safety rules. Report all unsafe matters, near misses, and accidents. Preferred candidate profile Educational qualification and work experience Educational qualification: A Diploma or B.Pharm. Minimum work experience: 4 to 6 years of experience in batch formulation operations Skills & attributes Technical Skills Proficiency in comprehending and overseeing sterile and fill finish operations in pharmaceutical manufacturing, demonstrating familiarity with the processes involved. Practical experience and hands-on knowledge in executing sterile and fill finish operations, showcasing the ability to actively participate in and manage these critical manufacturing processes. Practical expertise in equipment validation, process validation, and cleaning validation, demonstrating the ability to validate and ensure the reliability of manufacturing equipment and processes. Behavioral skills Effective listening skills, ensuring a comprehensive understanding of information. A keen eye for detail, ensuring accuracy and precision in tasks. Awareness and sensitivity to deadlines, ensuring timely completion of tasks. Analytical skills and the ability to troubleshoot, enabling effective problem-solving. Strong interpersonal skills and the ability to work well in a team, fostering collaboration and positive team dynamics. Location: Pydibhimavaram Dr Reddy's Formulations Limited(DFL-02) Injectable Facility, Aseptic Manufacturing Hiring For : Filling,Compounding,Autoclave,Lyo Operators, PM(Preventive Maintenance),Documentation, MS Office

Job Role: Junior/ Assistant Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/ BSc (Full time) Years of Experience: 1 to 6 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.