Job Description
Position: Sr Process Engineer
Duration: 12+ Months
Schedule: Full-Time, Onsite
Industry: Sterile Pharmaceutical Manufacturing
Schedule: Full-Time, Onsite
Industry: Sterile Pharmaceutical Manufacturing
I am looking for a Senior Process Engineer to lead technology transfer and process validation activities for sterile injectable manufacturing programs. This position will support the transfer of new products and processes into GMP commercial manufacturing, including manufacturing readiness, engineering batches, PPQ, and technical troubleshooting.
Responsibilities
- Lead technology transfer for sterile injectable and aseptic manufacturing processes.
- Develop and execute transfer plans, validation protocols, PPQ protocols, reports, risk assessments, and gap assessments.
- Support engineering, demonstration, qualification, and PPQ batches.
- Define critical process parameters, critical quality attributes, sampling plans, and acceptance criteria.
- Support aseptic filling, formulation, compounding, sterile filtration, sterilization, and lyophilization processes.
- Investigate process deviations and support root-cause analysis, CAPA, and change controls.
- Partner with MSAT, Manufacturing, Quality, Validation, Engineering, and Regulatory teams.
- Track project timelines, technical risks, manufacturing readiness, and transfer deliverables.
- Ensure compliance with cGMP, FDA, EU Annex 1, and process validation requirements.
Requirements
- Bachelor’s degree in Engineering or a related scientific discipline.
- Must have 5–10+ years of sterile injectable or aseptic pharmaceutical manufacturing experience to include Sterile injectables, biologics, vaccines, or parenteral drug products or Vial or syringe filling, formulation, compounding, sterile filtration, or lyophilization.
- Product transfers between manufacturing sites, CMOs, or CDMOs.
- Continued process verification, statistical trending, and commercial manufacturing support.
- Hands-on experience leading technology transfer and process validation/PPQ.
- Experience authoring and executing protocols, reports, risk assessments, deviations, and change controls.
- Strong knowledge of GMP manufacturing, validation lifecycle practices, and sterile processing.
- Strong technical writing, troubleshooting, project coordination, and cross-functional leadership skills.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Numbers & Facts
| Location | Greensville, NC |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1969 |
| Website | http://www.sterling-engineering.com |
About Company
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
Skills
- Asepsisunmatched
- CMOSunmatched
- Change Controlunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Drug Manufacturingunmatched
- Drug Productsunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Identify Issuesunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing/Industrial Processesunmatched
- Process Engineeringunmatched
- Process Validationunmatched
- Project Trackingunmatched
- Project/Program Coordinationunmatched
- Regulationsunmatched
- Requirements Validation/Verificationunmatched
- Risk Analysisunmatched
- Root Cause Analysisunmatched
- Sterilizationunmatched
- Technical Leadershipunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Vaccinationunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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