Process Engineer

POSITION OVERVIEW:

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 (SUS) design, implementation, and operational support.
• Experience with process characterization, process validation, and lifecycle management.
• Demonstrated experience supporting engineering runs, qualification activities, and manufacturing start-ups.
• Experience performing technical gap assessments, risk evaluations, and process readiness reviews.

Knowledge, Skills, and Abilities:

• Strong knowledge of GMP regulations, validation principles, and quality risk management practices.
• Familiarity with technology transfer methodologies and lifecycle management.
• Excellent technical writing, documentation, and presentation skills.
• Strong problem-solving and root cause investigation capabilities.
• Ability to influence stakeholders and lead cross-functional teams in a matrix environment.
• Strong organizational and project management skills with the ability to manage multiple priorities simultaneously.
• Experience working with CDMOs, CMOs, or external manufacturing partners is preferred.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.