Process Validation Engineer or Specialist I, II, III, or Sr.

Grand River Aseptic Manufacturing, Inc. • Grand Rapids, MI

5d • Onsite

About The Position

The Process Validation Engineer or Specialist supports validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to: validation of manufacturing processes and production equipment.

Requirements

• A minimum of 1-4 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is required for a level I.
• A minimum of 3-5 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is required for a level II.
• A minimum of 4-6 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is required for a level III.
• Senior level - 6 plus years of pharmaceutical industry experience or equivalent combination of education and experience required (4 years of experience with a master’s degree in engineering or life sciences, or 2 years of experience with a PhD in engineering or life sciences).
• Proficient computer skills in Microsoft Word, Excel, and Outlook.
• Demonstrated project management and leadership skills.
• Must be open to working in and supporting a 24/7 manufacturing environment.
• Work is occasionally performed in a cleanroom environment as required to support process validation activities.

Nice To Haves

• Completion of a bachelor’s degree in engineering or life sciences is highly desired.
• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
• Knowledge of GAMP5, ISPE Baseline Guide for Commissioning and Qualification, Annex 1 and FDA process validation guidance preferred.

Responsibilities

• Assist with maintaining and revising validation procedures.
• Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
• Establish and execute programs covering manufacturing processes, equipment, and cleaning.
• Assure that all validation is performed to conform to GRAM’s and cGMP requirements.
• Provide validation support to internal customers such as Technical Services, Quality Control, Manufacturing, and other users of validation services.
• Provide validation support to external customers and attend client meetings.
• Demonstrate knowledge of GRAM's tech transfer process and provide professional interactions with clients during tech transfer activities.
• Write, review, and execute protocols.
• Write, review, and execute studies for process improvement and scale up projects.
• Provide technical support to Manufacturing – troubleshooting and resolving process related issues.
• Proactively and regularly communicate with the project team to update on validation status.
• Identify process improvement opportunities and equipment needs for manufacturing/packaging.
• Develop and execute Deviations and CAPAs based on validation changes.
• Maintains equipment logbooks and other forms for document use, proper cleaning, and sterilization.
• Support Agency, customer, and vendor audits as needed.

Benefits

• Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost!
• Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well.
• Generous off-shift premiums!
• 16 hours of paid volunteer time per calendar year!
• Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year.
• Employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose.
• 10 paid holidays per calendar year with immediate eligibility!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree