Senior Project Engineer

Job Description

Job Description

Manus works across industries and value chains to accelerate the transition to BioAlternatives – better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our platform is proven to work across scales, bridging the Valley of Death between lab and manufacturing more efficiently and more reliably to deliver the benefits of synthetic biology today.

The Senior Project Engineer provides technical and project management leadership in support of Pilot Plant operations within a cGMP biotech manufacturing environment. This role is responsible for driving capital and facility projects from concept through commissioning, ensuring that pilot-scale processes are scalable, compliant, and aligned with commercial manufacturing standards. The Senior Project Engineer partners cross-functionally with Process Development, Manufacturing, Quality, EHS, and Facilities to deliver projects on time, on budget, and in compliance with regulatory requirements.

Why work at Manus:

• Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.
• Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.
• Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that comes with working on the cutting edge.

Responsibilities:

Project Leadership & Execution

• Lead end-to-end project management for pilot plant capital, facility, and equipment projects, including scope development, scheduling, budgeting, and vendor management.
• Develop and maintain project charters, schedules (MS Project / Smartsheet), risk registers, and change control documentation.
• Manage design firms, contractors, and equipment vendors through procurement, installation, qualification, and commissioning phases.
• Coordinate project activities to minimize impact to ongoing pilot plant operations and comply with cGMP requirements.

Pilot Plant Technical Support

• Serve as the primary engineering point of contact for day-to-day technical support of pilot plant equipment and systems (bioreactors, chromatography skids, TFF/UF systems, CIP/SIP, utilities).
• Troubleshoot process and equipment issues; lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
• Author and review engineering documents including P&IDs, equipment specifications, SOPs, and validation protocols (IQ/OQ/PQ).
• Support technology transfer activities from Process Development to Pilot Plant, and from Pilot Plant to commercial manufacturing scale.

Regulatory Compliance & Quality

• Ensure all engineering work is performed in accordance with applicable cGMP, FDA 21 CFR Parts 210/211 (or equivalent), and site quality standards.
• Support regulatory inspections and audits; provide technical responses to observations and inquiries related to facility and equipment systems.
• Participate in change control, deviation, and CAPA processes as a technical subject matter expert (SME).

Continuous Improvement & Sustainability

• Identify and champion process and facility improvement opportunities to increase operational efficiency, reduce cycle time, and lower cost.
• Drive EHS compliance and integrate sustainability objectives into engineering design and project execution.
• Mentor junior engineers and provide technical guidance to operations staff.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, or a closely related discipline.
• Minimum 6–8 years of progressive engineering experience in biotech, pharmaceutical, or life sciences manufacturing.
• Demonstrated experience managing capital projects ($500K–$5M+) in a cGMP environment.
• Proficiency with upstream and/or downstream bioprocessing equipment and unit operations.
• Strong knowledge of FDA cGMP regulations, GEP, and validation lifecycle (IQ/OQ/PQ).
• Experience authoring P&IDs, equipment specifications, and technical engineering documents.
• Proficient in project scheduling tools (e.g., MS Project, Smartsheet) and Microsoft Office Suite.