Sr. Validation Engineer or Specialist Sterility Assurance

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. Sterility Assurance Validation Engineer or Specialist supports validation of cGMP equipment, facilities and processes as it relates to sterility assurance. These duties will include, but are not limited to validation of autoclaves, depyrogenation equipment, critical utilities, production equipment, and manufacturing processes.

Non-Negotiable Requirements:

• Bachelor's degree in Engineering to be considered for Engineer role. Bachelor's degrees in Life Sciences or related will be considered for 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.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• A minimum of 5 years related work experience in a pharma, biopharma, and/or biotech manufacturing environment. Experience with focus on sterile processing is preferred.
• Knowledge of PDA guidance related to sterilization and aseptic process simulation and ISPE Baseline Guides for Commissioning and Qualification is preferred.

Responsibilities Include (but are not limited to):

• Develop, implement, and maintain sterility assurance strategies, policies, and procedures applicable to all sterile processing facilities at GRAM.
• Work under minimal supervision to provide sterility assurance oversight to commissioning and qualification activities, ensuring adherence to internal and external requirements.
• Validate and qualify equipment and systems as related to sterilization both upon initial validation and requalification.
• Responsible for generating documentation for assigned projects in the areas of sterilization equipment and processes, aseptic processing simulations, critical utilities qualification, and cleaning.
• Utilize risk assessment tools to identify and mitigate risk related to sterility assurance.
• Review and approve validation protocols/reports, change control documents, work orders, and document change requests.
• Liaise with external customers providing project updates and guidance on product specific needs for sterile processing.
• Identify process improvement opportunities and equipment needs for sterility assurance.
• Provide guidance and training to junior level validation engineers on practices, protocol authoring, and protocol execution.
• Establish and maintain good practices with regards to processes and /or internal conditions leading to an aseptic environment.
• Demonstrate superior project management skills and leadership qualities.

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.