Process Manager
Pinnaql
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a Process Manager who will provide 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. This onsite opportunity can be based in Cincinnati, OH; Chicago, IL; Boston, MA; or Barceloneta, PR, and requires approximately 25% travel. 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. 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 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. Availability to work extended hours, including weekends and holidays. Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. #J-18808-Ljbffr
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