Sr. Validation Engineer

Grand River Aseptic Manufacturing; Grand Rapids (MI); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to improving lives through quality and collaboration. As a Sr. Validation Engineer, you will play a crucial role in ensuring compliance with cGMP regulations in a dynamic manufacturing environment. This position offers the opportunity to validate essential equipment and processes, driving improvements and supporting audits. With a commitment to employee well-being, the company provides comprehensive medical benefits from day one, generous PTO, and opportunities for paid volunteerism. If you are passionate about making a difference and have the required experience, this is the perfect opportunity for you.

Benefits

Medical benefits from day 1

Paid volunteerism

Up to 13 days PTO

Wellness time off

10 paid holidays

Qualifications

• 5+ years of experience in pharma, biopharma, or biotech manufacturing.
• Knowledge of cGMPs for API facilities and pharmaceutical manufacturing.

Responsibilities

• Validate cGMP equipment, facilities, and processes.
• Conduct validation studies and develop test scripts.
• Prepare documentation for projects and support audits.

Skills

cGMP knowledge

Validation Engineering

Microsoft Word

Microsoft Excel

Microsoft Outlook

Education

Bachelor's degree in Engineering

Tools

GAMP5

ISPE Baseline Guides

Job description

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? 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 Sr. Validation Engineer supports validation of cGMP equipment, facilities, and processes. Responsibilities include validation of laboratory systems, production equipment, manufacturing processes, and utilities.

Non-Negotiable Requirements:

• Bachelor's degree in Engineering required.
• At least 5 years of related experience in pharma, biopharma, or biotech manufacturing.
• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing, clean rooms, utilities, and packaging.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Willingness to work in a 24/7 manufacturing environment.

Preferred Requirements:

• Knowledge of GAMP5, ISPE Baseline Guides, FDA process validation guidance preferred.

Responsibilities Include:

• Validate cGMP equipment, facilities, and processes, including laboratory systems, production equipment, manufacturing processes, and utilities.
• Conduct validation studies.
• Use risk assessments to identify critical validation areas and develop test scripts.
• Review and approve validation protocols, reports, change controls, work orders, non-conformance reports, and change requests.
• Communicate regularly with the project team regarding validation status.
• Identify process improvements and equipment needs for manufacturing and packaging.
• Prepare documentation for projects.
• Maintain good practices to ensure aseptic conditions.
• Support audits by agencies, customers, and vendors.

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, dental, vision, life insurance, and disability coverage for you and your family from day one, with 75% of costs paid by the company. Immediate 100% vesting in 401(k) contributions and company match. Generous off-shift premiums available.

Paid volunteerism starting day 1: 16 hours of paid volunteer time per year to give back to the community.

PTO: Up to 13 days per year, with flexible use for vacation, sick, or mental health needs.

Wellness time off: 1 hour of time off for every 30 hours worked, to use as you see fit.

Paid holidays: 10 paid holidays per year, immediately available.

Pay: Competitive and based on experience, discussed during the interview.

If you meet the above criteria, GRAM encourages you to apply today!