Senior Specialist, Global Engineering Solutions

About the role

The Senior Specialist will join a high‑performing team at our Rahway, New Jersey site, focusing on process design, execution and startup for Small Molecule High Potency/API/Containment projects. Reporting to the Technical Director, the role supports capital project delivery and technical startup, with exposure to multiple business areas.

Key responsibilities

• Interface with Integrated Project Team members and vendors to deliver capital projects on schedule and within budget.
• Lead technical design workshops, develop equipment URS, and assess design options.
• Perform technical reviews of PFDs and P&IDs, ensuring compliance with corporate standards and process safety requirements.
• Provide subject‑matter expertise in PHA/HAZOP/LOPA sessions and act as primary commercial and technical interface with equipment vendors.
• Lead factory acceptance testing, commissioning, qualification activities and peer reviews for assigned packages.

Required profile

• Minimum 5 years of engineering experience in the pharmaceutical/biotech industry.
• Strong understanding of API manufacturing processes, containment engineering, and relevant regulations (GMP, NEC electrical classification).
• Proven ability to lead technical teams, manage change, and communicate effectively across global stakeholders.

Required skills

• PFD/P&ID development and review
• Hazard analysis methods (PHA, HAZOP, LOPA)
• Equipment specification and URS creation
• API/HPAPI containment and chemical handling
• Commissioning, qualification, and factory acceptance testing
• Knowledge of NEC electrical classification, PSV selection, and process safety standards