Process Validation Engineer or Specialist I, II, III, or Sr.

TEST369; Grand Rapids (MI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Prescription coverage

Dental insurance

Vision insurance

Life insurance

Disability benefits

401(k) immediate vesting

Paid volunteer time

Job summary

TEST369 is seeking a Process Validation professional to support validation of cGMP equipment, facilities, and processes in a fast-paced, high-standards environment. The role includes validating manufacturing processes and production equipment, and coordinating with Technical Services, Quality Control, and Manufacturing teams.

Ideal candidates will have pharma/biotech manufacturing experience, strong project management skills, and comfort with 24/7 operations.

Qualifications

• A minimum level of project management and leadership experience is required.
• Proficiency with Microsoft Word, Excel, and Outlook is required.

Responsibilities

• Assist with maintaining and revising validation procedures.
• Establish and maintain good practices to support aseptic environments.
• Develop and execute validation programs for manufacturing processes, equipment, and cleaning.
• Provide validation support to internal customers and attend client meetings.
• Write, review, and execute protocols and studies for process improvement and scale up.

Skills

Project management

Leadership

Education

Bachelor's degree in engineering or life sciences

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

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,

Overview of this Position:

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

Non-Negotiable Requirements:

• A minimum of 1-4 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is required for a level I.
• A minimum of 3-5 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is required for a level II.
• A minimum of 4-6 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is required for a level III.
• Senior level - 6 plus years of pharmaceutical industry experience or equivalent combination of education and experience required (4 years of experience with a master’s degree in engineering or life sciences, or 2 years of experience with a PhD in engineering or life sciences).
• Proficient computer skills in Microsoft Word, Excel, and Outlook.
• Demonstrated project management and leadership skills.
• Must be open to working in and supporting a 24/7 manufacturing environment.
• Work is occasionally performed in a cleanroom environment as required to support process validation activities.

Preferred Requirements:

• Completion of a bachelor’s degree in engineering or life sciences is highly desired.
• 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 manufacturing processes, equipment, and cleaning.
• 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.
• Provide validation support to external customers and attend client meetings.
• Demonstrate knowledge of GRAM's tech transfer process and provide professional interactions with clients during tech transfer activities.
• 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 CAPAs based on validation changes.
• Maintains equipment logbooks and other forms for 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:

• 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.