R415978 Sr. Technician, Manufacturing Shared Services Operations (Hiring Our Heroes Corporate Fellow)

Merk • Rahway, NJ

2d • $68,000 - $107,000 • Onsite

About The Position

Pharmaceutical Operations and Clinical Supply is seeking a highly motivated fellow for an R&D Operations role at the Rahway, New Jersey Formulation, Laboratory, and Experimentation (FLEx) Center. The role supports drug product development and GMP clinical supply of sterile dosage forms as part of the FLEx-Sterile Manufacturing Shared Services team, which supports sterile supply, aseptic formulation, and visual inspection.

The position involves hands-on processing activities, including equipment assembly and disassembly, sterile processing, inventory management, open aseptic formulation in an isolator, closed formulation in a Grade C environment, and manual visual inspection of filled units such as vials and syringes. There may be opportunities to cross-train in other areas, including filling. The fellow will partner with formulation development colleagues to support process understanding and knowledge capture, and may provide feedback on product and process development.

The role requires adherence to GMP procedures, careful GMP documentation, proficiency with electronic systems, and participation in continuous improvement projects. It may also support commissioning, qualification, and demonstration of new equipment and technologies. The position collaborates with team members and partner groups, including formulators, engineers, Quality, Safety, and Facilities management. It is based in Rahway, NJ and is 100% on-site.

This is an unpaid, 12-week training fellowship hosted by the company and aligned with DoD SkillBridge guidelines. It is not an offer of employment, and participants are ineligible for employment benefits. It is exclusively for active participants in the Hiring Our Heroes Corporate Fellowship Program. Candidates must be transitioning service member fellows completing the program within the last 180 days of transition from military service.

Requirements

• High school diploma or GED and at least 5 years of pharmaceutical manufacturing or processing experience; or an associate degree in a science- or engineering-related field and at least 3 years of pharmaceutical manufacturing experience; or a bachelor's degree in Engineering Technology or a related field.
• Relevant GMP pharmaceutical experience or equivalent experience, such as chemical, nuclear, or military experience.
• Experience operating isolator machines and/or Grade A aseptic experience.
• Demonstrated written and verbal communication skills.
• Proficiency with computer systems and applications, including Microsoft Office (Word, Excel, and Outlook), equipment HMIs, MODA, PAS-X, SAP, and calibration/maintenance database systems.
• Ability and willingness to lift 50 pounds, bend, stoop, squat, crawl, twist, climb ladders, and don and wear cleanroom protective gowning, including respirators.
• Ability to work and communicate both independently and as part of a team.
• Willingness and flexibility to work overtime; overtime flexibility is required in manufacturing.
• Ability to work 100% on-site in Rahway, New Jersey.
• Must be an active participant in the Hiring Our Heroes Corporate Fellowship Program and a transitioning service member fellow completing the program within the last 180 days of transition from military service.

Nice To Haves

• Familiarity with regulatory requirements and Good Documentation Practices (GDP).
• Experience with highly complex and state-of-the-art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, SAP, or other ERP systems.
• Associate degree in science or a related field.
• BioWork Certificate for work in an FDA- or similarly regulated industry.
• Experience with automated systems such as MES, SAP, or similar systems.
• Demonstrated troubleshooting and problem-solving skills.
• Demonstrated ability to identify and initiate process improvements.
• Knowledge of PAS-X is preferable.

Responsibilities

• Read, understand, and follow drawings to assemble sterile equipment used in clinical development and manufacturing processes.
• Operate and maintain cleaning and sterilization equipment, including parts washers, dry heat ovens, and autoclaves.
• Receive, inspect, and store sterile supplies and equipment, maintaining inventory levels and organization in the sterile supply area.
• Prepare and formulate sterile products according to established protocols and batch records, including closed formulation and open aseptic activities inside a Grade A isolator.
• Perform visual inspections of products and components for defects, inconsistencies, and non-conformities, managing large quantities of units.
• Maintain accurate records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.
• Follow GMP guidelines and SOPs to ensure the quality and safety of clinical production lots; identify and address compliance, environmental, safety, and process deviations as appropriate and notify management.
• Adapt to changes in batch procedures and production schedules, applying flexibility and problem-solving skills.
• Gown and work in Grade C conditions while maintaining good aseptic cleanroom behaviors.
• Maintain electronic records of sterilization processes, inventory levels, and equipment logs.
• Communicate clearly and collaborate with team members and other teams to ensure timely delivery of supplies.
• Assist in training new staff on sterile supply procedures and protocols and GMP adherence.
• Identify and escalate issues, perform basic troubleshooting, and capture learnings to improve systems and processes.
• Organize and prioritize work to meet shop-floor priorities, identify discrepancies in advance, and communicate schedule-adherence risks.
• Participate in safety, quality, and process-improvement initiatives to enhance flexibility, efficiency, and compliance.
• Redline SOPs for continuous improvement.
• Support investigations and implementation of corrective and preventive actions.
• Support commissioning, qualification, and demonstration of new equipment and technologies as needed.
• Partner with formulation development colleagues to improve process understanding and knowledge capture, including providing feedback on product and process development.

Benefits

• The posting describes a comprehensive benefits package for employees, including medical, dental, vision, and other insurance benefits for employees and family; retirement benefits including 401(k); paid holidays; vacation; and compassionate and sick days. Fellowship participants are ineligible for employment benefits.

What This Job Offers

• Career Level: Mid Level
• Education Level: High school or GED