Project Engineer

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

Key Responsibilities:

• Design Review: Review of engineering design packages, including vendor submittals, for compliance with Vertex standards, building codes, operational requirements, and maintenance expectations. Specification Review and Development: Review, update, or creation of technical specifications for equipment and facility systems.
• Technical Oversight: Engineering oversight across design, fabrication, installation, and start up. Coordination with architects and engineers (referred to as A and E firms), vendors, construction teams, and internal stakeholders. Participation in schedule reviews, technical risk assessments, and mitigation planning.
• Change Control Management: Authoring, executing, reviewing, and owning change controls consistent with Vertex standard operating procedures (SOPs), Quality Assurance (QA) requirements, Engineering expectations, Facilities guidelines, and GMP regulatory frameworks.
• Technical Reviews and Documentation:
• Review, modification, and approval of engineering drawings, piping and instrumentation diagrams (referred to as P and IDs), submittals, standard operating procedures (referred to as SOPs), and technical literature.
• Development of redlines, as-built documentation, and engineering updates Commissioning and Qualification Support: Commissioning activities for manufacturing and facility systems.
• Execution and review of Factory Acceptance Testing (referred to as FAT), Site Acceptance Testing (referred to as SAT), Installation Qualification (referred to as IQ), Operational Qualification (referred to as OQ), and other commissioning and qualification protocols. Support to validation teams to ensure system readiness and alignment with Quality and Regulatory requirements.
• Continuous Improvement and Deviation Resolution:
• Participation in deviation resolution, corrective and preventive actions (referred to as CAPA), and inspection readiness for regulatory audits.
• Troubleshooting and Issue Resolution: On floor equipment and system troubleshooting to restore operational capability and support continuous operations.
• Project, Startup, and Impairment Support: Support impairment and startup activities during construction, shutdowns, and project execution. Assist with system transitions to maintain business continuity.

Requirements:

• 5-7 years of exp. with ENG degree.
• Exp with oral solid dose, biotechnology, or other regulated pharmaceutical manufacturing environment performing Site / Facilities / Plant / Process Engineering activities in a GMP environment.
• Experience in creating and managing lifecycle documentation for manufacturing equipment, clean utilities, clean rooms, and HVAC systems (Impact Assessments, User Requirements, Functional Specifications, Software / Hardware Specifications, Factory Acceptance Tests, Site Acceptance Tests, and CQV protocols).
• Experience owning change controls in a GMP environment for manufacturing equipment, clean utilities, clean rooms, and HVAC systems.

Benefits:

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.