Validation & Engineering Group, Inc.

Process Manager

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  2 hours ago
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Job Description

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

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.

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Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
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