Scientist – Tech Ops

Scientist I – Tech Ops

Scientist I – Tech Ops Full-Time M-F, 1st Shift
- Possibly 1-2 days from home Compensation: $38-$41/hr Must be able to supply your own laptop

Kelly Science is currently seeking a Scientist I – Tech Ops for a long-term engagement at one of our Global clients in Summit, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, 401K, and annual performance reviews.

• Collect and review historical data.
• Initiate Development Plan for each formula.
• Assign Development Plan Deliverables to Cross Functional team partners.
• Coordinate with Team Members on their contributions to be included in the Development Plan.
• Route Development Plan and manage Approval Process.
• Initiate and write change controls.
• Route change controls and manage approval process.
• Create, update, revise, and manage approval process for specifications (Manufacturing Work Instructions, Formula/Device specification, Product specification, Finished Good specification) as required.
• Manage any BRF revision / modification process.
• Review Pilot/Trial Batch Cards submitted by Manufacturing Site.
• Write Bulk Holding Protocols and manage approval process as required.
• Review and Approve Validation(s) Batch Cards submitted by Manufacturing Site.
• Write the Process Development Summary.
• Provide MS&T deliverables to change controls or to Authorization for Product Release (APR).
• In conjunction with project manager, ensure that partners are providing deliverables to change controls or to APR.
• When all deliverables are provided, route change controls or APR for review and approval. Provide ongoing general assistance in various miscellaneous department activities.

• Provide ongoing solutions to general challenges and issues that arise.
• Support External Manufacturing Investigations.
• Provide technical justification to support change of equipment, manufacturing processes.
• Conduct technical review of site requests.
• Participate in regular cross-functional team meetings and deliver key milestones
• Work with cross functional partners to coordinate work, to get directions and alignment.

• Bachelors in Chemical Engineering, Biomedical Engineering, or similar (BS in Chemistry, Biochemistry, etc)
• 3+yrs of experience supporting technical writing, formulating/batching, and technical operations within a cGxP environment (pharma, biotech, or consumer products preferred)
• Must have experience handling site transfers/ equipment qualification/ investigations) and working on change control
• Technical
  
  Skills:
  
  Data analysis, change control, specification writing/revision, process/equipment justification.
• Project Management:
  Plan initiation, task delegation, cross-functional coordination, progress tracking.
• Communication:
  Excellent written/verbal skills, clear documentation.
• Analytical
  
  Skills:
  
  Data analysis, problem-solving.
• Additional:
  Manufacturing experience, GMP understanding, teamwork, attention to detail.