Process Validation Engineer or Specialist II

Description

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

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 other related field is required for the Specialist role.  
• A minimum of 3 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
• Proficient computer skills in Microsoft Word, Excel, and Outlook. 
• Demonstrated project management and leadership skills. 
• Must be open to working in a 24/7 manufacturing environment.

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 equipment, processes, cleaning, process, and computer system validation.
• 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.
• 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 CAPA based on validation changes.
• Review and approve forms associated with facility and equipment calibration, maintenance, etc.
• Maintains equipment logbooks and other forms to document use, proper cleaning, and sterilization.
• Support Agency, customer, and vendor audits as needed. 

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying on average 75% 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!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of 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.

If you meet the required criteria listed above, GRAM welcomes you to apply today!