Senior Technician, Filling Operations (Onsite)

Job Description

POCS Rahway : Technician Operations (FLEx Sterile Filling Technician)

Level : O3

Job Family : Manuf / Operations

Senior Technician Operations

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 :

Aseptic Processing : Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Experience with operating isolator filling machines is required.

Aseptic experience : Experience in working in Grade A environment is required including aseptic qualification and performing environmental monitoring.

Isolator Operation : Operate and maintain large complex isolators ensuring optimal performance and adherence to safety protocols.

Documentation : Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system. Knowledge of PAS-X is preferable.

GMP : 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.

Cleanroom Environment : Able to gown and work in Grade C conditions maintaining good aseptic cleanroom behaviors

Collaboration : Able to communicate clearly with team and work closely with other teams to ensure on time delivery.

Training and Compliance : Assist in training new staff on sterile supply procedures and protocols ensuring adherence to GMP standards.

Leadership : 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.

Schedule Adherence : Understands schedule adherence impact and communicates risk. Maintains a continuous improvement mindset and implements initiates to increase efficiency or reduce risk to schedule adherence.

Compliance : 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.

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.

Must be willing and able to lift 50 lbs bend stoop squat crawl twist climb ladders and don & wear cleanroom protective gowning including respirators.

Supports investigations and implementation of corrective / preventative actions.

Flexibility working overtime is a requirement in manufacturing

Supports investigations and implementation of corrective / preventative actions.

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.

Associates Degree in science or related field.

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.

First and second shift openings available

#MSJR

#eligibleforERP

#PSCS

Required Skills :

Biopharmaceutical Manufacturing CNC Operations Computer Literacy Data Analysis FDA Regulations Good Manufacturing Practices (GMP) Laboratory Techniques Manufacturing Quality Control Master Batch Records Material Selection Pharmaceutical Process Development Production Planning Regulatory Compliance Shift Work Teamwork

Preferred Skills :

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only :

Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit :

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only : We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status : Regular

Relocation : Domestic

VISA Sponsorship : No

Travel Requirements :

No Travel Required

Flexible Work Arrangements :

Not Applicable

Shift :

1st - Day 2nd - Evening

Valid Driving License :

No

Hazardous Material(s) :

n / a

Job Posting End Date :

12 / 5 / 2025

• A job posting is effective until 11 : 59 : 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Required Experience :

Senior IC

Key Skills

Experience Working With Students,Google Docs,Organizational skills,Classroom Experience,Data Collection,Materials Handling,Workers' Compensation Law,OSHA,Special Operations,Team Management,Experience with Children,Supervising Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1