Senior Validation Engineer

Grand Rapids, MI

Posted: 02/20/2023 Division: Life Sciences Job Number: JN -022023-16448

Job Description

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Senior Validation Engineer:
  • Title: Senior Validation Engineer
  • Location: Grand Rapids, MI
  • Industry: Pharmaceutical
  • Salary: Based on Experience
  • Employment Type: Direct Placement
Position summary:
Support validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to: and validation of laboratory systems, production equipment, manufacturing processes and utilities.

Essential Functions:
  • Responsible for preparing appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities.
  • Review and approve validation protocols/reports, change control documents, work orders, and document change requests.
  • Act independently with minimal supervision to conduct validation studies.
  • Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
  • Proactively and regularly communicate with the project team to update on validation status.
  • Identify process improvement opportunities and equipment needs for manufacturing/packaging.
  • Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
  • Demonstrate superior project management skills and leadership qualities.
  • Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
  • Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
  • Support Company s Core Values of Quality, Service, Collaboration, and Courage.
  • Support Agency, customer, and vendor audits as needed.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
  • Perform all other tasks, projects, and duties as assigned.
  • Assist with maintaining and revising validation procedures.
Work Experience and Skills:
  • A minimum of 5 years related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
  • Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification and ASTME2500, preferred.
  • Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
  • Has proven the ability to meet the requirements of the essential duties and responsibilities.
  • Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

  • Completion of a bachelor s degree in Engineering is required.

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
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