Sr. Technician, Filling Operations - Onsite (2nd Shift)
Merck, Rahway, NJ, United States
Senior Technician, Operations (FLEx Sterile Filling Technician)
Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile team, specifically in Filling.
This position will be responsible for hands-on processing activities that include sterile filling and lyophilization, and capping. There will be opportunity for technicians to cross-train in other parts of the process including thaw, formulation, visual inspection, and sterile supply. These individuals are expected to partner with, and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development.
These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.
Key Responsibilities:
Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Experience with operating isolator filling machines is required.
Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.
Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols.
Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system. Knowledge of PAS-X is preferable.
Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations. Able to report any recurring issues or trends to management for further investigation.
Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
Able to communicate clearly with team and work closely with other teams to ensure on time delivery.
Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
Able to identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes. Organizes and prioritizes own work to meet shop floor priorities and identifies discrepancies in advance. Also attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
Understands schedule adherence impact and communicates risk. Maintains a continuous improvement mindset and implements initiatives to increase efficiency or reduce risk to schedule adherence.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management. Able to redline SOPS for continuous improvement.
Supports investigations and implementation of corrective/preventative actions.
Positions are based in Rahway, NJ and 100% on-site.
Education Minimum Requirements :
High School Diploma/GED, with at least 5 years in pharmaceutical manufacturing or processing
OR Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing
OR Bachelors Degree in Engineering Technology or related field
Required Experience and Skills :
Relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience).
Demonstrated written and verbal communication skills.
Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.
Demonstrated ability to work and communicate both independently and as a part of a team.
Flexibility working overtime is a requirement in manufacturing
Preferred Experience and Skills :
Familiarity with regulatory requirements and Good Documentation Practices (GDP).
Experience with some of the following: highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, SAP or other ERP systems.
Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, MODA, PAS-X, SAP, Calibration/Maintenance Database Systems.
BioWork Certificate (working in an FDA or similar regulated industry).
Experience with automated systems (MES, SAP, or similar).
Demonstrated troubleshooting / problem-solving skills.
Demonstrated ability to identify and initiate process improvements.
The salary range for this role is:
$68,000 - $107,000
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile team, specifically in Filling.
This position will be responsible for hands-on processing activities that include sterile filling and lyophilization, and capping. There will be opportunity for technicians to cross-train in other parts of the process including thaw, formulation, visual inspection, and sterile supply. These individuals are expected to partner with, and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development.
These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.
Key Responsibilities:
Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Experience with operating isolator filling machines is required.
Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.
Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols.
Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system. Knowledge of PAS-X is preferable.
Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations. Able to report any recurring issues or trends to management for further investigation.
Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
Able to communicate clearly with team and work closely with other teams to ensure on time delivery.
Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
Able to identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes. Organizes and prioritizes own work to meet shop floor priorities and identifies discrepancies in advance. Also attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
Understands schedule adherence impact and communicates risk. Maintains a continuous improvement mindset and implements initiatives to increase efficiency or reduce risk to schedule adherence.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management. Able to redline SOPS for continuous improvement.
Supports investigations and implementation of corrective/preventative actions.
Positions are based in Rahway, NJ and 100% on-site.
Education Minimum Requirements :
High School Diploma/GED, with at least 5 years in pharmaceutical manufacturing or processing
OR Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing
OR Bachelors Degree in Engineering Technology or related field
Required Experience and Skills :
Relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience).
Demonstrated written and verbal communication skills.
Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.
Demonstrated ability to work and communicate both independently and as a part of a team.
Flexibility working overtime is a requirement in manufacturing
Preferred Experience and Skills :
Familiarity with regulatory requirements and Good Documentation Practices (GDP).
Experience with some of the following: highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, SAP or other ERP systems.
Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, MODA, PAS-X, SAP, Calibration/Maintenance Database Systems.
BioWork Certificate (working in an FDA or similar regulated industry).
Experience with automated systems (MES, SAP, or similar).
Demonstrated troubleshooting / problem-solving skills.
Demonstrated ability to identify and initiate process improvements.
The salary range for this role is:
$68,000 - $107,000
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.