Lead Candidate · 2 weeks ago
Technical Transfer Engineer
Fishers, IN
Full-time
Onsite
Entry, Mid Level
1+ years expINCOG is a world-class CDMO for parenteral injectable drugs, and they are seeking a Technical Transfer Engineer to support all facets of tech transfer, process validation, and GMP floor support. This role involves scaling up processes for manufacturing and providing technical oversight to ensure robust production processes.
EmploymentHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Harley Pearce
Responsibilities
The Technical Transfer Engineer is responsible for autonomously scaling up and transferring process into full scale manufacturing process based on data generated internally or received from the client
Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Diagram, Summary Reports and Process FMEA
Represents TSMS in project teams and communicates directly with customers. Recognized as Subject Matter Expert for the manufacturing processes
Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
Monitor Process Data, identify trends and propose actions as necessary
Leads technical troubleshooting and investigations of process issues to support root cause analysis, product impact assessment and effective corrective and preventive actions
Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
Collaborate with cross-functional team to assess and implement new technology for GMP manufacturing
Able to assess impact of changes to the product, process, equipment, procedures and/or materials
Manage timelines and appropriately prioritize critical path tasks to meet deadlines
Other responsibilities as required
Qualification
Required
Bachelors' degree in Science or Engineering
1-3 years of GMP experience required
Experience in Technical Transfer for pharmaceutical or related industry
Preferred
Masters' degree in Science or Engineering preferred
Benefits
Paid time off, based on tenure
11 paid holidays
401(k) plan with company match up, vested immediately
Choice of health & wellness plans
FSA and HSA options
Onsite wellness facility
Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Company
Lead Candidate
Lead Candidate is a recruiting company that provides staffing, talent management, and HR solutions for the pharma sector.
Founded in 2021Newcastle Upon Tyne, Newcastle upon Tyne, GBR
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Fiona Cruickshank
Founder and Director
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