Sr. Process Engineer at Syner-G BioPharma Group

Newark, Delaware, United StatesFull-timeCapital ProgramsPosted 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><div> POSITION OVERVIEW: Syner-G is seeking a Senior Process Engineer with 8+ years of experience in oral solid dose (OSD) pharmaceutical manufacturing to lead process optimization and commercial manufacturing support activities. This role is centered on improving and sustaining robust OSD processes across granulation, compression, coating, and packaging operations. The Senior Process Engineer will support technology transfer from development to commercial manufacturing, troubleshoot complex process and yield issues, and provide technical leadership during PPQ and continued process verification activities. Acting as a key technical partner to MSAT, Manufacturing, QA, and Engineering, this individual will drive process robustness, efficiency, and compliance across client programs. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) <ul> <li>Lead process optimization for oral solid dose manufacturing processes, including granulation, compression, coating, and packaging.</li> <li>Support technology transfer activities from development and pilot operations into commercial manufacturing, ensuring process scalability, robustness, and reproducibility.</li> <li>Troubleshoot process deviations, yield losses, equipment challenges, and cycle time constraints in commercial OSD manufacturing environments.</li> <li>Provide technical support for process validation activities, including PPQ execution and continued process verification.</li> <li>Collaborate closely with MSAT, Manufacturing, Quality, and Engineering teams to resolve technical issues and implement sustainable process improvements.</li> <li>Develop and maintain process documentation such as process descriptions, equipment specifications, risk assessments, and technical reports.</li> <li>Conduct data analysis and performance trending to identify root causes, variability drivers, and improvement opportunities.</li> <li>Support commissioning, qualification, and start-up activities for OSD manufacturing equipment.</li> <li>Drive continuous improvement initiatives focused on throughput, yield, cost reduction, and GMP compliance.</li> <li>Mentor and support junior engineers by providing technical guidance and process expertise.</li> </ul> QUALIFICATIONS AND REQUIREMENTS: Education <ul> <li>BS or MS in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical field.</li> </ul> Experience <ul> <li>8+ years of experience in oral solid dose pharmaceutical manufacturing.</li> <li>Hands-on experience with tablet presses, granulators, fluid bed systems, and coating equipment.</li> <li>Demonstrated experience supporting tech transfer and commercial manufacturing operations.</li> <li>Direct involvement in PPQ, continued process verification, and commercial process support.</li> <li>Proven ability to collaborate in cross-functional GMP environments.</li> </ul> Technical Skills <ul> <li>Strong knowledge of GMP requirements and pharmaceutical manufacturing regulations.</li> <li>Solid understanding of OSD unit operations, process controls, and equipment capabilities.</li> <li>Experience investigating deviations, leading root cause analyses, and implementing corrective and preventive actions.</li> <li>Strong communication skills and the ability to serve as a technical lead across functions.</li> <li>Ability to manage multiple priorities in a fast-paced manufacturing environment.</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 or manufacturing 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. If a physical location is preferred, office locations are available 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.  </div>

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