Specialist, Engineering; Onsite

Job Description Non-Sterile Specialist, Engineering Position Summary

This Engineer position provides on-site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non-sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift), Monday through Friday, is required to meet operational needs.

The FLEx facility supports formulation and filling activities for clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) products, including process development, scale-up, launch and transfer to the supply network, and process optimization for commercial products.

The primary responsibility of this role is to maintain facility, utilities, and manufacturing equipment in compliance with GMP and Safety requirements while applying Reliability Maintenance best practices to support timely availability of clinical and development batches. This includes troubleshooting equipment, partnering with GES, Facilities Management, OEMs, and vendors, and providing engineering and compliance support for non-sterile process equipment and utilities.

The role operates with minimal supervision and serves as a technical and compliance resource during second shift operations. Responsibilities include supporting equipment validation from commissioning through decommissioning, managing changes and periodic reviews, investigating deviations, issuing Quality Notifications, identifying root causes and CAPAs, maintaining GMP documentation, supporting clinical operations, managing purchase orders and capital requests, coordinating installation and commissioning of new equipment, and supporting regulatory interactions as an SME when needed.

• Bachelor's degree in engineering plus a minimum of 2 years of related experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats.

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Oral Solid Dosage (OSD) Drug Product manufacturing equipment and process.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Troubleshooting ability (mechanical/electrical/automation)
• Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.
• Effective organizational skills.
  
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• Effective communication and technical writing skills.
• Strong computer skills

• Maintenance & Engineering techniques and management and Capital Project management.
  
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• Independent problem- solving.
• SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)
• eVal/Kneat- - Paperless electronic validation system
• Experience with Pro Cal as a Computerized Calibration Maintenance System (CCMS).
• Familiarity with Planning and Scheduling practices as well as business/financial practices.
  
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• The candidate should be able to work independently and lead or facilitate tasks successfully.

Adaptability, Biopharmaceuticals, cGMP Guidelines, Electronic Batch Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Pharmaceutical Biology, Pharmaceutical Manufacturing, Pharmaceutical Sciences, Pharmacodynamics, Pharmacotherapeutics, Process Optimization, Product Formulation, Standard Operating Procedure (SOP) Writing

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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 characteristics.

--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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