Sterility Assurance Sr. Validation Engineer or 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 Sterility Assurance Sr. 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.
• More than 6 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.
• Must be open to working in a 24/7 manufacturing environment.

Preferred Requirements:

• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes (primarily filling activities, but drug product/substance knowledge is beneficial as well), 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):

• 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:

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.