Sr Manager Aseptic Process Engineering
Sr Manager Aseptic Process Engineering
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5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Technical SME
- Serve as aseptic filling SME with command of typical sterile fill finish unit operations which may include aseptic and T.S. bag filling aseptic liquid/ lyo vials aseptic syringes/ cartridges T.S. LVP bottles Compounding CIP/SIP systems washing equipment autoclaves isolators clean utilities (i.e. PW WFI CS PS).
- Provide feasibility analysis and technical guidance on the design project management commissioning and start-up of equipment and sterile fill finish facilities (both brownfield and greenfield).
- Develop and review project descriptions plans timelines resources requirements costs and other associated sterile fill finish project details.
- Develop and review manufacturing risk assessments related to equipment process quality and manufacturability changes.
- Mentor others on effective technical problem solving and process control.
Sustaining Technical Stewardship
- Identifies technology/ supplier landscape and contributes to equipment design install and qualification.
- Technical review of site Standard Operating Procedures requirements specifications regulatory filings and/ or other controlled documents as needed.
- Tracks and trends relevant technical and business process metrics to ensure fill/finish platforms are performing optimally and efficiently.
- Contributes to key technology transfers manufacturability investigations technology adoption and continuous improvement initiatives.
New Platforms and Growth
- Drives innovation in fill finish manufacturing equipment and techniques through partnerships with internal R&D engineering and external technology suppliers.
- Leads the implementation of strategic new fill finish platforms from feasibility to EPCM to verification and validation.
- Develops first-of-kind technology User Requirements.
Relationship Management
- Maintain strong partnerships with Pharma Operations Manufacturing Strategy R&D Sterility Assurance and EHSS.
- Ensure alignment with Integrated Supply Chain leadership priorities and strategies.
- Uses technical expertise to influence decision making to a non-technical audience
- Contribute to new technology platform governance actions.
- Manage other engineering design firms equipment vendors construction firms and internal/external partners as required to complete projects.
Requirements
- Bachelor s degree in life sciences or engineering
- 7 years of relevant experience in highly automated fill finish project execution.
- 10 years of proven experience in cGMP manufacturing environment and familiarity with formulation aseptic filling and visual inspection of liquid and lyophilized injectable products in bags vials and syringes.
- Strong process control competence design thinking and technical feasibility analysis.
- Bilingual (Spanish/English)(Write/Speak)
- Ability to drive deliverable completion/ results and work effectively.
- Ability to lead and manage change be decisive and focused.
Employment Type
Full Time
