Sr Manager Aseptic Process Engineering

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Sr Manager Aseptic Process Engineering with experience in regulated industry.  Will provide manufacturing engineering leadership and support to a diverse integrated supply chain by partnering with the extended Pharma Engineering function, site engineering, and other Pharma Operations partners. As an integral member of a matrix/multi-functional team, you will serve as an aseptic unit operation technical SME, lead and improve the rigor of fill finish sustaining technology selection and deployment at the site level, and develop strategic roadmaps and feasibility for the implementation of Pharma segment innovation and growth platforms.

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.

• 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.

All your information will be kept confidential according to EEO guidelines.