Engineering Lead

3 weeks ago

Round Lake, United States BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

**Your role at Baxter**:
**This is where your expertise helps people**:
As the Pharma segment lead for sterile fill finish facilities, you 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 difficulty 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.

Your resilience and tenacity in the pursuit of exceptional sterile fill finish technical stewardship will enable Baxter’s mission to save and sustain lives.

**What you'll be doing**:

- 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.
- 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.
- 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.
- 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.

**What you'll bring**:

- Bachelor’s degree in life sciences or engineering.
- 7+ years of relevant experience in highly automated fill finish project execution (ideally having served as a disciple lead for a large capital project >$10M USD).
- 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.
- Excellent interpersonal and communication (oral and written) skills.
- Ability to drive deliverable completion/ results and work effectively in highly matrixed organizations.
- Ability to lead and manage change, be decisive and focused.
- Being open to new insights, and desire to challenge the status quo.
- Demonstrated ability to work effectively with diverse groups of multi-functional partners across all levels of the organization and superior influencing skills.

**Equal Employment Opportunity**

Baxter is an equal opportunity employer. Baxter ev

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