Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this 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.

Non-Negotiable Requirements:

• Completion of a bachelor’s degree in Engineering is required for the Engineer role. Completion of a bachelor’s degree in life sciences or another related field is required for the Specialist role.
• 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. 

Preferred Requirements:

• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
• Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification, Annex 1 and FDA process validation guidance preferred.

Responsibilities Include (but are not limited to):

• 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.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: 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. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness time off for every 30 hours worked, to use how you choose. 

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.