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 Sterility Assurance Validation Engineer/Specialist I/II/III is responsible for supporting validation of cGMP equipment, facilities and processes as it relates to sterility assurance. These duties will include, but are not limited to validation of autoclaves, depyrogenation equipment, critical utilities, cleaning, production equipment, and manufacturing processes (aseptic process simulation, decontamination, etc).

Non-Negotiable Requirements:

• For Sterility Assurance Validation Engineer/Specialist I: Up to 3 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment
• For Sterility Assurance Validation Engineer/Specialist II: 3 to 5 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
• For Sterility Assurance Validation Engineer/Specialist III: More than 5 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
• Bachelor’s degree in Engineering is required for the Engineer role. Bachelor’s degree in life sciences or other related field is required for the Specialist role.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.
• Must be open to working onsite and supporting a 24/7 manufacturing environment.
• Work is occasionally performed in a cleanroom environment as required to support sterility assurance validation activities.

Preferred Requirements:

• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes (primarily filling activities, but drug product/substance knowledge is beneficial as well), 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):

• Support and maintain sterility assurance strategies, policies, and procedures applicable to all sterile processing facilities at GRAM.
• Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
• Assure that all validation is performed to conform to GRAM’s and cGMP requirements.
• Provide sterility assurance support to internal customers such as Technical Services, Quality Control, Manufacturing and other users of validation services.
• Support validation and requalification of equipment and systems as related to sterilization.
• Write, review, and execute studies for sterilization processes, aseptic processing simulations, and cleaning.
• Maintains equipment logbooks and other forms to document use, proper cleaning and sterilization.
• 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 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.