Grand River Aseptic Manufacturing · 3 months ago
Process Validation Engineer or Specialist II
Grand River Aseptic Manufacturing Inc.
Full-time
Onsite
Mid Level
3+ years expGrand River Aseptic Manufacturing (GRAM) is dedicated to improving lives every day and is seeking a Process Validation Engineer or Specialist II. The role involves supporting the validation of cGMP equipment, facilities, and processes, ensuring compliance with industry standards while collaborating with various internal teams.
Pharmaceuticals
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 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
Qualification
Required
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
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
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 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!
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