Syner-G
Sr. Process Engineer
Newark, Delaware, United States · Senior
No sponsorshipDetected 36 days ago
Data AnalysisProcess ImprovementCustomer SupportMechanical DesignGMPLeadershipCommunication
About the role
- This role is centered on improving and sustaining robust OSD processes across granulation, compression, coating, and packaging operations.
Responsibilities
- Lead process optimization for oral solid dose manufacturing processes, including granulation, compression, coating, and packaging.
- Support technology transfer activities from development and pilot operations into commercial manufacturing, ensuring process scalability, robustness, and reproducibility.
- Provide technical support for process validation activities, including PPQ execution and continued process verification.
- Collaborate closely with MSAT, Manufacturing, Quality, and Engineering teams to resolve technical issues and implement sustainable process improvements.
- Develop and maintain process documentation such as process descriptions, equipment specifications, risk assessments, and technical reports.
- Support commissioning, qualification, and start-up activities for OSD manufacturing equipment.
- Drive continuous improvement initiatives focused on throughput, yield, cost reduction, and GMP compliance.
- Mentor and support junior engineers by providing technical guidance and process expertise.
- Acting as a key technical partner to MSAT, Manufacturing, QA, and Engineering, this individual will drive process robustness, efficiency, and compliance across client programs.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements
- 8+ years of experience in oral solid dose pharmaceutical manufacturing.
- Hands-on experience with tablet presses, granulators, fluid bed systems, and coating equipment.
- 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.
- Travel to client sites may be required up to 100%, based on project demands and client expectations.
- 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.
Skills
- Strong knowledge of GMP requirements and pharmaceutical manufacturing regulations.
- Solid understanding of OSD unit operations, process controls, and equipment capabilities.
- Experience investigating deviations, leading root cause analyses, and implementing corrective and preventive actions.
- Physical Demands:
- reach with hands and arms
- Work Environment:
- A career here is life-enhancing.
- Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
- For more information, visit www.Synergbiopharma.com
Compensation
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
Benefits
- This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities.
- Specific vision abilities required by this position include close vision and the ability to adjust focus.
- 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.
Company info
- We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars.
Equal opportunity
- LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers.
Visa & Work Authorization
- Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
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This listing is sourced directly from Syner-G's careers page and normalized into a canonical job model.