Title : Senior Process Development Engineer
Location: New Albany, OH (Onsite)
Employment Type: Contract
Duration : 12 Months
Job Responsibilities
- Provide technical leadership for automated and semi-automated packaging equipment and device assembly supporting commercial GMP Final Drug Product (FDP) operations.
- Lead equipment characterization to establish process parameters, operating ranges, and appropriate controls.
- Lead commissioning, qualification, and validation (CQV) activities for GMP equipment.
- Develop and manage technical documentation, including protocols, reports, risk assessments, and equipment verification records.
- Support technical transfer of products to the Ohio site and drive improvements in packaging line capacity, performance, and efficiency.
- Lead deviation, CAPA, and change control activities.
- Troubleshoot equipment, monitor performance trends, and support equipment standardization.
- Collaborate with Manufacturing, Engineering, Quality, Clinical and Commercial Operations, and equipment suppliers.
- Drive continuous improvement initiatives to enhance productivity, throughput, and operational performance.
Required Qualifications
- Bachelor's degree in Engineering or a related technical field preferred, with 4+ years of GMP experience.
- Hands-on experience supporting highly automated or semi-automated packaging equipment and manufacturing operations.
- Strong knowledge of GMP requirements, equipment verification, technical writing, and CQV execution.
- Experience establishing equipment operating parameters and supporting process optimization.
- Experience with technical documentation, deviations, CAPAs, and change control.
- Strong troubleshooting, communication, and cross-functional project leadership skills.
- Flexibility to work 12-hour rotating shifts, including days, evenings, nights, and weekends. The role will initially start on day shift before transitioning to evening shifts.
Preferred Qualifications
- Experience with combination product assembly equipment and integrated packaging lines.
- Direct experience in medical devices, combination products, or pharmaceutical packaging operations.
- Familiarity with Kneat or Veeva.
- Experience managing equipment suppliers and leading technical transfers.
- Willingness to travel internationally to Europe or Canada, potentially up to 10%.
Pay Scale
- Anticipated hourly pay range: $48 $52/hr on W2.
Benefits
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.