Process Validation Engineer/Specialist I/II - Continued Process Verification (CPV)

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 Process Validation Engineer/Specialist coordinates and supports Continued Process Verification (CPV) activities at GRAM. Responsible for generating and executing validation protocols, validation reports, risk assessments, and procedures. Support audits and represent Validation in client interactions. Support validation projects and guidance in technical decision-making related to CPV responsibilities. These duties include, but are not limited to the statistical analysis and evaluation of the status of process validation of commercially marketed product materials and manufacturing processes.

Non-Negotiable Requirements:

• 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.

Responsibilities Include (but are not limited to):

• 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.

Full job description available during formal interview process. If you meet the required criteria listed above, GRAM welcomes you to apply today!

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 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!

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