Senior Lead Engineer - Manufacturing & Tech Ops (Travel)

PerkinElmer; Trenton (NJ); Vor Ort; USD 89.000 - 120.000; Vollzeit

Zusammenfassung

Project Farma, a PerkinElmer company, seeks a Lead Engineer for manufacturing and tech operations. This full-time salaried role supports complex technical programs, including technology transfers and process validations, with travel to client sites across the United States.

The successful candidate will apply deep technical delivery skills, mentor engineers, and partner with cross-functional teams to meet regulatory commitments and deliver high-quality outcomes for life sciences projects.

Qualifikationen

• Bachelor’s Degree in Life Science, Engineering, or related field.
• 4–7 years in engineering or operations within pharma/biotech environments.
• Strong understanding of cGMP regulations and regulatory guidelines.
• Ability to interpret technical documentation and drawings.
• Excellent organizational, communication, and stakeholder management skills.
• Willingness to travel for client projects.

Aufgaben

• Lead end-to-end program management for complex technical operations initiatives (NPI, technology transfers, process validations).
• Develop integrated program plans, critical path analyses, risk registers, and resource plans.
• Contribute to stage-gate processes and governance deliverables to meet milestones and regulatory commitments.
• Coordinate cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory, Supply Chain, and Engineering.
• Translate scientific and process requirements into executable operational plans and CPP/CQA awareness.
• Support technology transfer activities from development into GMP manufacturing, including documentation and readiness reviews.
• Resolve technical, operational, and quality issues during operations, startup or shutdown of equipment.
• Develop manufacturing batch records, SOPs or validation protocols as required.
• Perform operational readiness assessments covering equipment, facility, process, and staff readiness.
• Coach and develop a team of technical professionals to deliver high-quality work.

Kenntnisse

Program management

Cross-functional collaboration

Regulatory compliance

Documentation

Problem solving

Ausbildung

Bachelor’s Degree in Life Science or Engineering

Tools

IQ/OQ/PQ

Jobbeschreibung

Project Farma, a PerkinElmer company, seeks a Lead Engineer for manufacturing and tech operations. This full-time salaried role supports complex technical programs, including technology transfers and process validations, with travel to client sites across the United States.

The successful candidate will apply deep technical delivery skills, mentor engineers, and partner with cross-functional teams to meet regulatory commitments and deliver high-quality outcomes for life sciences projects.