Equipment Project Engineer

Position: Project Engineer

Job Description: Our client is seeking two experienced Project Engineer contractors to support some regulatory and CAPA-driven projects within a pharmaceutical manufacturing environment. These roles are critical in helping the organization address data integrity gaps, digitalization efforts, and manufacturing equipment improvements following internal regulatory assessments. These Project Engineers will be responsible for managing and executing equipment related projects across the drug substance manufacturing process. These projects are heavily timeline-driven and regulatory-focused, requiring strong project management skills and the ability to operate independently with minimal oversight. These individuals will develop and manage project schedules, identify key stakeholders, drive accountability, and ensure actions are completed within defined regulatory timeframes.

Key Responsibilities

• Lead and execute CAPA-driven and regulatory-focused engineering projects and manage detailed project timelines using MS Project (or similar tools)
• Identify critical path activities and drive on-time completion
• Coordinate cross-functionally with Automation, Instrumentation, QA Validation, Manufacturing, Systems Engineering teams, etc.
• Support equipment upgrades, instrumentation installs, automation enhancements, and data integrity initiatives
• Facilitate meetings, track deliverables, and hold stakeholders accountable
• Support change management activities as needed

Projects may involve a wide range of drug substance manufacturing equipment and systems, including:

· Skidded process systems

· CIP skids

· Bioreactors

· Centrifuges

· Purification and chromatography column skids

· TFF systems

· Instrumentation upgrades and digital transmitters

· Automation and connectivity to data historians

Candidates do not need deep CSV expertise but must possess enough engineering knowledge to understand equipment function, process flow, instrumentation impact, and system integration.

Qualifications:

· Engineering degree required – mechanical or chemical engineering preferred

· 5–15 years of pharmaceutical/biopharmaceutical engineering experience

· Strong project management experience within GMP environments

· Experience managing equipment-related projects

· Proficiency in MS Project or similar scheduling software

· Ability to identify critical path and manage timelines effectively

· Self-starter who can quickly ramp up and adapt to shifting project priorities

SKILLS: Engineering, Project Management, Data Integrity, Change Controls, Pharmaceutical, Remediation, MS Project (or similar), Drug Substance, Manufacturing Equipment