Sr. Fill Finish Process Engineer (Future Opportunities) at Syner-G BioPharma Group

San Diego, California, United StatesFull-timeGMP & OperationsPosted about 2 months ago

About the Role

<div class="content-intro">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 <a href="https://www.youtube.com/watch?v=2rUMvtncuw8">here</a>.  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.  For more information, visit <a id="menur1aj1" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="https://www.synergbiopharma.com/" target="_blank">www.Synergbiopharma.com</a></div>POSITION OVERVIEW: We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish 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. We are actively seeking qualified candidates to join our talent pipeline for future client engagements.   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.) <ul> <li>Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.</li> <li>Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.</li> <li>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.</li> <li>Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.</li> <li>Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.</li> <li>Partner with Operations and MS\&T to troubleshoot and resolve technical issues.</li> <li>Collaborate with Maintenance and Reliability teams to address equipment performance gaps.</li> <li>Support continuous improvement and process optimization initiatives.</li> <li>Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.</li> <li>Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.</li> <li>Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.</li> <li>Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.</li> <li>Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.</li> <li>Develop and execute commissioning and qualification protocols.</li> <li>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.</li> <li>Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines</li> <li>Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.</li> <li>Participate in project planning, scheduling, risk assessments, and milestone tracking.</li> <li>Provide effective communication to stakeholders at all levels.</li> </ul> QUALIFICATIONS AND REQUIREMENTS: Education <ul> <li>Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.</li> </ul> Experience <ul> <li>Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.</li> <li>Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.</li> <li>Experience supporting commercial manufacturing operations in a regulated environment.</li> <li>Experience with commissioning, qualification, and engineering documentation.</li> </ul> Knowledge, Skills, and Abilities <ul> <li>Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.</li> <li>Strong documentation and technical writing skills.</li> <li>Ability to manage multiple priorities in a fast-paced environment.</li> <li>Strong communication, analytical, and problem-solving skills.</li> <li>Ability to work independently and collaboratively.</li> </ul> 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 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.

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