Senior Specialist, Engineering; Onsite

Job Overview

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey houses a state‑of‑the‑art cGMP clinical supply manufacturing facility, FLEx Sterile. The role of Senior Specialist, Technical Operations Engineer focuses on supporting operations, troubleshooting equipment and driving continuous improvement initiatives to reduce cycle time, errors and costs.

• Support routine operations and promptly troubleshoot and resolve production equipment issues.
• Establish new processes and implement continuous improvement projects aimed at reducing cycle time, errors and costs.
• Collaborate with Production, New Product Introduction, Facilities, Equipment, Automation and Quality teams to ensure compliant, right‑first‑time execution and timely delivery of business goals.
• Provide second‑shift and occasional weekend coverage as needed to maintain continuity of operations.

• BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or a related engineering field.
• Minimum 5years of relevant experience in a sterile drug product manufacturing environment.
• Subject‑matter expertise with sterile processing equipment (e.g., automated filling lines, lyophilizers, autoclaves, part washers, isolators).
• Knowledge of automation systems such as PLC, DCS and MES.
• Experience in drug product aseptic processing techniques and GMP compliance (US and EU).
• Proficiency in preparing SOPs and GXP documents.
• Strong technical aptitude, critical thinking and troubleshooting skills.
• Project management experience leading cross‑functional initiatives with proven scope, timeline, risk and stakeholder management.
• Excellent communication, interpersonal and organizational skills.
• Lean Six Sigma Green Belt certification.

• Experience providing technical mentorship to engineers and cross‑functional teams.
• Experience with commissioning, qualification and validation of equipment.
• Knowledge of ISA
  88 and ISA
  95 principles, investigational drug regulatory requirements and clinical supply chain operations.
• Lean Six Sigma Black Belt certification.

Salary range: $ – $. Eligible for annual bonus and long‑term incentive if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.

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.