Grand River Aseptic Manufacturing · 2 weeks ago
Process Validation Engineer/Specialist I/II – Continued Process Verification (CPV)
Grand Rapids,MI,US
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expGrand River Aseptic Manufacturing (GRAM) is seeking a Process Validation Engineer/Specialist to coordinate and support Continued Process Verification (CPV) activities. The role involves generating and executing validation protocols, reports, and risk assessments, while ensuring compliance with cGMP and supporting validation projects.
Pharmaceuticals
Responsibilities
Support and maintain continued process verification strategies, policies, and procedures applicable to all manufacturing processes at GRAM
Assure that all validation is performed to conform to cGMP and GRAM requirements
Support validation report generation, sampling and data collection, and Statistical Process Control (SPC) strategies for both PPQ and CPV
Provide support to internal customers such as Technical Services, Quality Control, Manufacturing, and other users of Validation services
Prepare and perform execution of risk assessments, protocols, and reports
Store and maintain data integrity initiatives across multiple media platforms as dictated in regulatory guidelines as well as internal cGDP requirements
Support PPQ and CPV specific deviation investigations and implement CAPA based on validation changes
Review change control documents, work orders, and document change requests to assess impact on validated processes and/or systems
Work cross functionally to establish project schedules
Ensure that report completions meet department and company timeline metrics in fast paced environment
Proactively and regularly communicate with project teams to update on validation status
Identify process improvement opportunities for manufacturing and finishing operations
Open to a flexible and fluid work environment. Work on any assignment as directed and provide flexibility to support
Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practices
Support Agency, customer, and vendor audits as needed
Qualification
Required
Bachelor's degree in Life Sciences or Engineering related field is required
For Level I: Up to 3 years' related work experience in a pharma, biopharma, and/or biotech manufacturing environment
For Level II: 3+ years' work experience in a pharma, biopharma, and/or biotech manufacturing environment
Prior experience and working knowledge of Statistical Process Control (SPC) software
Knowledge of relevant PDA guidance and 2011 FDA Guidance for Industry Process Validation: General Principles and Practices
Knowledge of cGMPs for Aseptic Processing facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations
Proficient computer skills in Microsoft Word, Excel, and Outlook
Benefits
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 for 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!
Company
Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing (GRAM) is a leading contract development and manufacturing organization (CDMO) specializing in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges.
201-500 employees
H1B Sponsorship
Grand River Aseptic Manufacturing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
Funding
Current Stage
Growth StageLeadership Team
Nick Bykerk, CPA
Chief Financial Officer
Bernie King
Chief Operating Officer
Company data provided by crunchbase