Sr. Technician, Operations (Onsite)

Job Description

POCS Rahway: Sr. Technician Operations

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 Manufacturing Shared Services which supports sterile supply aseptic formulation and visual inspection.

This position will be responsible for hands-on processing activities that include equipment assembly and disassembly sterile processing inventory management open aseptic formulation in an isolator and closed formulation activities in a Grade C environment and manual visual inspection of filled units (i.e. vials or syringes).

There is also opportunity to cross-train in other areas such as 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:

• Assembly: Able to read understand and follow drawings to assemble sterile equipment to utilize in clinical development and manufacturing processes.

• Sterilization Processes: Operate and maintain cleaning and sterilization equipment including parts washers dry heat ovens and autoclaves.

• Supply Management: Receive inspect and store sterile supplies and equipment ensuring proper inventory levels and organization within the sterile supply area.

• Sterile Formulation: Prepare and formulate sterile products according to established protocols and batch records ensuring accuracy and compliance with GMP standards. Able to perform closed formulation activities as well as open aseptic activities inside a Grade A isolator. Experience with operating isolator machines and/or Grade A aseptic experience is required.

• Visual Inspection: Perform visual inspections of products and components to identify defects inconsistencies and non-conformities. Individual should be detailed and organized and able to manage a large quantity of units.

• Attention to Detail: Maintain meticulous records of formulation processes including ingredient quantities equipment used and environmental conditions.

• GMP Compliance: Follow all GMP guidelines and standard operating procedures (SOPs) to ensure the quality and safety of clinical production lots. Identifies and addresses compliance environmental safety and process deviations as appropriate while notifying management.

• Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules demonstrating flexibility and problem-solving skills.

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

• Documentation: Maintain accurate records of sterilization processes inventory levels and equipment logs in an electronic system. Knowledge of PAS-X is preferable.

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

• 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.

• Good eyesight to perform detailed inspections

• 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.

• 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

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The salary range for this role is:

$70300 - $110700

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 employees 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

Required Skills:

Preferred Skills:

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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

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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.

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