Process Engineer Pharmaceuticals I
Job Location:
Job Location:
Durham County, NC - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
30+ days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
For further inquiries about this opportunity please contact one of our Talent Specialists Hema Malini at Sri at (or) Remy at .
Title: Process Engineer Pharmaceuticals I
Duration: 7 Months
Location: Research Triangle Park NC
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Job Description:
Client is seeking a contract Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support of AAV (rAAV) vector research and late-stage clinical gene therapy programs.
This role is execution-focused supporting upstream and downstream manufacturing operations routine experiments and process development studies working in close coordination with manufacturing and MSAT staff. The contractor will contribute to the timely completion of manufacturing and laboratory studies data collection and manufacturing readiness ensuring alignment with existing protocols to support early-stage gene therapy programs technology development and internal research priorities.
This is a laboratory-based contract role intended to support day-to-day manufacturing and experimental execution working closely with pre-clinical manufacturing and MSAT scientists. This role does not carry people-management or long-term program ownership responsibilities and is well suited for individuals who thrive in an execution-driven environment.
Key Responsibilities
- Execute routine and defined rAAV manufacturing and laboratory activities for research and GLP-grade studies following established protocols and batch records.
- Perform hands-on upstream and downstream operations including:
- Cell culture and maintenance
- Vector production in shake flasks WAVE bioreactors and/or stirred-tank bioreactors
- Centrifugation filtration chromatography and related purification steps
- Support process development and experimental studies including process characterization and robustness testing at small and pilot-scale by executing assigned experiments and manufacturing runs according to approved protocols batch records and study plans ensuring accurate data generation and traceability.
- Maintain clear real time and accurate documentation of laboratory activities experimental results and manufacturing data in paper or electronic systems in accordance with department procedures to ensure compliance and data integrity.
- Assist with batch record completion data compilation and data review.
- Communicate experimental progress observations and results to project stakeholders in a clear and timely manner.
- Support manufacturing investigations and troubleshooting activities including execution of confirmatory experiments and data collection to inform root-cause analysis.
- Contribute to technical protocols experimental reports and summary presentations describing executed work and generated data as needed.
- Support daily laboratory operations including:
- Equipment setup operation and routine maintenance
- Coordination and execution of laboratory activities
- Maintaining a clean organized and inspection-ready lab environment
- Ensuring materials consumables and reagents are available for assigned experiments in coordination with lab management and solution prep teams.
- Follow established safety procedures SOPs and documentation practices at all times.
- Adhere to all safety quality and data integrity requirements during laboratory and manufacturing-support activities.
Required Qualifications
- BS or MS degree in a biological or engineering discipline required (Biotechnology Chemistry/Biochemistry Chemical/Biochemical Engineering or equivalent)
- Minimum 2 years (BS)/0 years (MS) of relevant experience in laboratory research biologics manufacturing and a desire to continue in a laboratory-focused role preferably within:
- Manufacturing
- MSAT
- Process Development
- Experience or familiarity with upstream and/or downstream bioprocess operations
- Comfort executing experiments under direction following protocols and meeting scheduled deliverables
- Ability to work on-site in a fast-paced laboratory environment
Preferred Experience
- Prior exposure to cGMP manufacturing environments or manufacturing-support laboratories
- Hands-on experience executing scale-up scale-down or process characterization experiments
- Familiarity with DOE concepts and experimental execution (design and analysis support may be provided by others)
- Experience using JMP or similar statistical tools (execution-focused)
- Strong working knowledge of Microsoft Word Excel and PowerPoint
- Excellent attention to detail and data accuracy
- Ideal Contractor Profile
- Execution-oriented with a strong preference for hands-on laboratory work
- Comfortable working under established protocols and technical direction
- Organized reliable and able to manage assigned experiments independently once trained
- Adaptable to changing project priorities and manufacturing timelines
- Collaborative team player who communicates clearly with scientists engineers and manufacturing stakeholders
- Willing to support on-site manufacturing or lab schedule needs including periodic weekend coverage.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
