Process Manager

Posted 2 Days Ago
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Cambridge, MA, USA
In-Office
Senior level
Biotech • Consulting • Pharmaceutical • Manufacturing
The Role
Serve as SME for biologics process design, validate engineering deliverables, act as owner's representative, challenge technical assumptions, support project managers, align design with operations, and reduce execution risk across capital projects.
Summary Generated by Built In

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

  • Process Manager

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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

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.

#LI-ONSITE

Skills Required

  • 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
  • Experience working with EPC firms, engineering contractors, and multidisciplinary project teams
  • Strong understanding of engineering design principles, process integration, and facility design requirements
  • Ability to independently assess technical solutions and challenge engineering assumptions
  • Strong technical problem-solving and decision-making skills
  • 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, including possible weekends and holidays
  • Willingness to travel approximately 25% to visit other sites
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The Company
154 Employees
Year Founded: 2019

What We Do

Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.

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