Sr. Process Engineer
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Job Location:
Waltham, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
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 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 BioSpaces 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.
POSITION OVERVIEW:
We are seeking a Sr. FillFinish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fillfinish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation sterile filtration aseptic filling lyophilization capping inspection processes and associated equipment technologies along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations QA validation MS&T engineering and supply chain to ensure robust compliant and continuously improving manufacturing performance.
WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)
- Support design construction installation and qualification of a new commercial fillfinish suite including cleanrooms process utilities and supporting infrastructure.
- Contribute to user requirement development equipment specifications vendor evaluations and design reviews.
- Support FAT/SAT commissioning and qualification activities for fillers isolators or RABS lyophilizers depyrogenation tunnels autoclaves CIP/SIP systems formulation vessels sterile filtration skids and inspection machines.
- Conduct field walkdowns verify installation details and ensure alignment with drawings P&IDs and GMP requirements.
- Serve as subject matter expert for fillfinish operations including formulation filtration filling lyophilization capping and visual inspection.
- Partner with Operations and MS&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA Validation and MS&T to maintain validated state of aseptic manufacturing processes.
- Ensure alignment with regulatory requirements including FDA EMA ICH and Annex 1.
- Support continued process verification (CPV) annual product review (APR/PQR) and ongoing process monitoring.
- Author review and approve GMP documentation including batch records SOPs change controls CAPAs deviations and technical reports.
- Generate and maintain engineering lifecycle documentation including impact assessments URS/FRS documents FAT/SAT packages and turnover packages.
- Develop and execute commissioning and qualification protocols.
- Utilize systems such as building management systems process control systems and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
- Ensure all work complies with GMP standards safety expectations and regulatory guidelines
- Coordinate across engineering operations facilities quality and validation to ensure successful project execution.
- Participate in project planning scheduling risk assessments and milestone tracking.
- Provide effective communication to stakeholders at all levels.
QUALIFICATIONS AND REQUIREMENTS:
Education
- Bachelors or Masters degree in Chemical Mechanical Biomedical Pharmaceutical Engineering or a related technical field.
Experience
- Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
- Strong preference for sterile aseptic biologics or vaccine fillfinish experience.
- Experience supporting commercial manufacturing operations in a regulated environment.
- Experience with commissioning qualification and engineering documentation.
Knowledge Skills and Abilities
- Strong understanding of aseptic operations cleanroom environments and fillfinish equipment.
- Strong documentation and technical writing skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong communication analytical and problem-solving skills.
- Ability to work independently and collaboratively.
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 employers. 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 employees 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.
Required Experience:
Senior IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
The world’s leading CMC & Regulatory Affairs solutions provider for biopharma. Consulting solutions in CMC 360, global regulatory affairs & medical writing.
