Process Engineer Plainville, Massachusetts, United States

Syner-G BioPharma Group; Plainville (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Syner-G BioPharma Group in Plainville, MA, is seeking an experienced Process Engineer to lead and support the transfer of manufacturing processes across development, clinical, and commercial sites.

The ideal candidate will have a strong background in process engineering, technology transfer, single-use systems, risk management, and GMP manufacturing, with extensive cross-functional collaboration across site functions and external partners.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or related field and 5+ years in pharma/biotech or medical device manufacturing.
• Experience leading or supporting technology transfer projects within pharma/biotech manufacturing.
• Strong understanding of upstream, downstream, fill-finish, or related manufacturing processes.
• Hands-on experience with single-use systems (SUS) and related deployment.

Responsibilities

• Lead initial technology transfer assessments between development, clinical, and commercial sites.
• Develop and execute technology transfer strategies to support clinical and commercial programs.
• Define CPPs, KPPs, CQAs, and operating ranges; support process characterization and monitoring.
• Coordinate CQV/PPQ activities and provide engineering run support.
• Collaborate cross-functionally with Process Development, Manufacturing, Engineering, Validation, Quality, and Supply Chain.

Skills

Process engineering

Technology transfer

Single-use systems

Risk management

GMP manufacturing

Cross-functional collaboration

Process characterization

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Plainville, Massachusetts, United States

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

We are seeking an experienced Process Engineer to lead and support the successful transfer of manufacturing processes and technologies between development, clinical, and commercial manufacturing sites. This individual will play a critical role in evaluating technical readiness, identifying and mitigating transfer risks, and ensuring smooth implementation of manufacturing processes across internal and external facilities.

The ideal candidate brings strong expertise in process engineering, technology transfer, single-use systems (SUS), process characterization, risk management, and GMP manufacturing. This role requires extensive cross-functional collaboration with Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external partners to ensure successful process implementation and operational readiness.

WORK LOCATION:

Travel to client sites may be required up to 100%, based on project demands and client expectations.

KEY RESPONSIBILITIES:

• Lead initial technical and manufacturing gap assessments between sending and receiving sites.
• Identify process, equipment, facility, material, documentation, and organizational capability gaps that may impact successful technology transfer.
• Develop and execute technology transfer strategies to support clinical and commercial manufacturing programs.
• Track technical risks, action items, decisions, and project deliverables through completion.
• Support manufacturing readiness activities and process implementation at receiving sites.
• Develop detailed process descriptions, process flow diagrams (PFDs), process maps, and supporting technical documentation.
• Define Critical Process Parameters (CPPs), Key Process Parameters (KPPs), Critical Quality Attributes (CQAs), and operating ranges.
• Support process characterization activities and process performance monitoring.
• Provide technical support during engineering runs, process qualification campaigns, investigations, and manufacturing start-up activities.
• Troubleshoot process issues and implement effective corrective and preventive actions as required.
• Support the design, specification, and evaluation of single-use systems and assemblies.
• Define process flow requirements, component selection, equipment interfaces, operational requirements, and implementation strategies.
• Collaborate with engineering, operations, and suppliers to support successful SUS deployment and lifecycle management.
• Develop risk-based sampling plans for engineering studies, qualification activities, process validation, and routine manufacturing.
• Facilitate and support process risk assessments using established quality risk management methodologies.
• Identify technical risks and develop appropriate mitigation strategies.
• Support commissioning, qualification, validation (CQV), and process performance qualification (PPQ) activities, including protocol development, execution support, and deviation resolution.
• Support the development, review, and approval of technology transfer protocols, manufacturing batch records, SOPs, specifications, validation documents, and readiness assessments.
• Ensure all project activities comply with GMP requirements, regulatory expectations, and internal quality standards.
• Support audit readiness activities and regulatory inspections as required.
• Coordinate activities across Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external partners.
• Serve as a technical subject matter expert during transfer planning, execution, and post-transfer support.
• Provide technical guidance and mentorship to project teams and manufacturing personnel.
• Effectively communicate project status, technical risks, and recommendations to stakeholders and leadership.

QUALIFICATIONS & REQUIREMENTS:

Education:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments

Technical Experience:

Experience leading or supporting technology transfer projects within pharmaceutical or biotechnology manufacturing.

Strong understanding of upstream, downstream, fill-finish, or related manufacturing processes.

Hands-on experience with single-use systems (S