Process Engineer - Oral Solid Dosage (Granulation, Compression, Coating)
Stark Pharma Solutions Inc
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Job summary
Stark Pharma Solutions Inc in the United States is seeking an experienced Process Engineer to support Oral Solid Dosage manufacturing operations in a cGMP environment, with a strong emphasis on technology transfer. This hands-on role leads transfer of products and processes from development to commercial manufacturing, ensuring readiness and knowledge transfer.
The ideal candidate has a solid background in blending, granulation, milling, compression, encapsulation, coating and packaging, plus
Qualifications
- Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences or related discipline.
- Hands-on experience with OSD unit operations: blending, granulation, milling, compression, encapsulation, coating and packaging.
- Technology transfer experience into commercial manufacturing.
- Experience supporting PPQ and process characterization.
- Working knowledge of cGMP requirements and commercial manufacturing operations.
- Experience with change control, deviation investigation and CAPA.
- Strong technical writing and problem-solving skills.
- Must be legally authorized to work in the United States.
- W2 employment only.
Responsibilities
- Coordinate cross-functional technology transfer activities from development, pilot or external sites into commercial manufacturing.
- Support scale-up efforts and drive execution of engineering, validation and manufacturing readiness activities.
- Perform process optimization and troubleshoot manufacturing issues on OSD unit operations.
- Evaluate process performance data and author technical protocols and reports.
- Support process characterization and PPQ activities.
- Manage change controls and lead deviation investigations and CAPAs.
- Partner with Manufacturing, Quality Assurance, Engineering, MS&T and Regulatory teams.
Skills
Education
Job description
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.
Our client, a mid-size pharmaceutical CDMO, is seeking an experienced Process Engineer to support Oral Solid Dosage manufacturing operations in a cGMP environment, with a strong emphasis on technology transfer. This role leads and supports the transfer of products and processes from development, pilot or external manufacturing sites into commercial manufacturing, ensuring process knowledge is transferred effectively and manufacturing readiness is achieved.
This is a hands-on OSD role. Candidates whose experience is in medical device, software validation, or non-pharmaceutical manufacturing will not be a fit.
- Coordinate cross-functional technology transfer activities from development, pilot or external sites into commercial manufacturing
- Support scale-up efforts and drive execution of engineering, validation and manufacturing readiness activities
- Perform process optimization and troubleshoot manufacturing issues on OSD unit operations
- Evaluate process performance data and author technical protocols and reports
- Support process characterization and Process Performance Qualification (PPQ) activities
- Manage change controls and lead deviation investigations and CAPAs
- Partner with Manufacturing, Quality Assurance, Engineering, MS&T and Regulatory teams
- Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences or related discipline
- Hands-on experience with OSD unit operations: blending, granulation, milling, compression, encapsulation, coating and packaging
- Demonstrated technology transfer experience into commercial manufacturing
- Experience supporting PPQ and process characterization
- Working knowledge of cGMP requirements and commercial manufacturing operations
- Experience with change control, deviation investigation and CAPA
- Strong technical writing and problem-solving skills
- Must be legally authorized to work in the United States
- W2 employment only
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