Description:Provides expert technical oversight of biologics process design across capital projects, acting as an owner's representative to ensure engineering quality, process integrity, and alignment with operational requirements. Supports project teams by independently validating design deliverables and challenging technical assumptions to ensure robust, compliant, and efficient project execution. This is an onsite opportunity and can be based in any of the following locations: Cincinnati OH, Chicago IL, Boston MA, or Barceloneta PR. Candidates should be open to around 25% travel as needed to visit other sites.
Responsibilities:- Serve as Subject Matter Expert (SME) in biologics process design and operations.
- Review and validate engineering designs developed by EPC and engineering partners.
- Act as owner's representative to ensure technical accuracy and compliance with project requirements.
- Challenge and verify process assumptions, design details, and engineering deliverables.
- Support Project Managers in technical decision-making and design resolution.
- Ensure alignment between design output, operational needs, and cost/schedule considerations.
- Provide detailed technical input to improve design quality and reduce execution risk.
- Evaluate engineering solutions to ensure process performance, operability, maintainability, and compliance with project objectives.
- Collaborate with engineering, operations, and project teams to resolve technical issues and support successful project delivery.
Qualifications:- Bachelor's Degree in Engineering, Biotechnology, Life Sciences, or related technical discipline.
- Experience in biologics manufacturing process design and operations.
- Strong knowledge of biologics process systems and manufacturing operations.
- Experience supporting capital projects within pharmaceutical or biotechnology manufacturing environments.
- Experience reviewing and validating engineering design packages and technical deliverables.
- Strong understanding of engineering design principles, process integration, and facility design requirements.
- Experience working with EPC firms, engineering contractors, and multidisciplinary project teams.
- Ability to independently assess technical solutions and challenge engineering assumptions.
- Strong technical problem-solving and decision-making skills.
- Ability to balance technical requirements with project cost, schedule, and operational objectives.
- Excellent communication, collaboration, and stakeholder management skills.
- Ability to provide technical leadership and influence project outcomes across cross-functional teams.
- Available to work extended hours, possibility of weekends and holidays.
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