Senior Process Controls Engineer

Senior Process Controls Engineer

The company's headquartered is in Massachusetts. They produce plant-based ingredients in their manufacturing facility using a variety of patented and proprietary microbial technologies. Our specialty products are in the field of food ingredients, flavors and fragrances, agricultural chemicals, and pharmaceuticals.

We are seeking a highly motivated Senior Process Controls Engineer to support manufacturing operations. This hands-on position requires a desire and ability to work as an integral part of a multidisciplinary team, as well as the demonstration of a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of the position. This person will be expected to play an integral part of the company's operations team.

The Senior Process Controls 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 Process Controls 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 for the Company:

• Opportunity – To be part in building a company focused on a future increasingly reliant on bio-manufacturing and making a sustainable and positive impact in the world.
• Accountability – You will build, manage and work in a hands-on environment to develop and articulate the company's product value propositions.
• Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that come with working on bringing cutting edge technologies to market.

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.

Other Duties

Please note this job description does not fully describe or provide a comprehensive list of all duties and responsibilities of the position. Duties and responsibilities, including essential functions, may vary amongst locations and/or individuals holding this job position, and may be added or changed without notice.

All qualified applicants will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability