MSAT Product and Process Support Specialist

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 MSAT Product and Process Support Specialist primary responsibility is to manage new equipment implementation and the technical responsibilities of the client manufacturing processes at Grand River Aseptic Manufacturing (GRAM). This includes the interpretation of client supplied documentation (i.e. batch records, product inserts, product proposal, work orders, etc.) and translating manufacturing and finishing requirements into GRAM specific batch records, specifications and procedures. Leads and/or works within cross-functional teams to support product scale-up, development and technical transfer to support Project Management, Manufacturing, Finishing, Quality Assurance, Quality Control, Business Development, and Validation.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or related field
• A minimum of 2-4 years' related work experience in a pharmaceutical, bio pharmaceutical, and/or biotechnology manufacturing environment.
• Experience and expertise in manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Knowledge of project management techniques and tools.
• Minimum of 2 years in an aseptic pharmaceutical manufacturing and/or finishing environment.
• Minimum of 1 year work experience in the capacity of MSAT or Technical Services preferred.

Responsibilities Include (but are not limited to):

• Conduct the identification and transfer of manufacturing processes from early-stage development through transition to commercial manufacturing.
• Conduct the identification and transfer of finishing processes (Terminal Sterilization, Inspection, Labeling and Packaging) from engineering through commercial finishing.
• Conduct new equipment and materials identification, evaluation, and procurement in support of new products, product scale up, and process improvements.
• Create and/or revise documentation in support of deviations, quality investigation and corrective actions.
• Work with Manufacturing, Finishing, Engineering, and Quality personnel to solve difficult technical problems, with Subject Matter Expertise (SME) in aspects of manufacturing and/or finishing environment.
• Recommend materials and component applications for new products (i.e. product contact material, filters, tubing, vials, stoppers, caps, cartons, labels, shippers, etc.).
• Directly support production with subject matter expertise to increase efficiency, solve problems, and troubleshoot issues.
• Prepare and conduct unassisted training of Manufacturing and Quality personnel for new product introduction, protocol execution and unique manufacturing processes.

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.