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. These duties will include validation of laboratory systems, production equipment, manufacturing processes, and utilities.

Non-Negotiable Requirements:

• 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 5 years related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
• 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 Requirements:

• Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification, and Annex 1 and FDA process validation guidance preferred.

Responsibilities Include (but are not limited to):

• Coordinate and oversee process validation activities (PPQ).
• Prepare appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities.
• Conduct validation studies.
• Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
• Write, review and approve validation protocols/reports, change control documents, work orders, non-conformance reports, and document change requests.
• Proactively and regularly communicate with the project team to update on validation status.
• Identify process improvement opportunities and equipment needs for manufacturing/packaging.
• Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
• Support Agency, customer, and vendor audits as needed.

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 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 17 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: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever 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. Shift differential available for second and third shift!