Sterility Assurance Principal 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 Principal 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 field will be considered for Specialist role.
• At least 10 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 GAMP 5, ISPE Baseline Guides for Commissioning and Qualification and ASTME2500 preferred. 
• Knowledge of PDA guidance related to sterilization and aseptic process simulation and ISPE Baseline Guides for Commissioning and Qualification is preferred.
• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
• Prior experience in a sterile processing environment preferred. 

Responsibilities Include (but are not limited to):

• Maintain equipment logbooks and other forms to document use, proper cleaning, and sterilization. 
• Provide technical support to Manufacturing – troubleshooting and resolving sterility related issues. 
• Write, review, and execute protocols. 
• Write, review, and execute studies for process improvement and scale up projects. 
• Demonstrate superior project management skills and leadership qualities.
• Develop, implement, and maintain sterility assurance strategies, policies, and procedures applicable to all sterile processing facilities at GRAM.
• Establish, execute, and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
• Identify process improvement opportunities and equipment needs for sterility assurance.
• Liaise with external customers providing project updates and guidance on product specific needs for sterile processing.
• Provide guidance and training to junior level validation engineers on practices, protocol authoring, and protocol execution.
• Responsible for generating documentation for assigned projects in the areas of sterilization equipment and processes, aseptic processing simulations, critical utilities qualification, and cleaning. 
• Review and approve validation protocols/reports, change control documents, work orders, and document change requests.
• Utilize risk assessment tools to identify and mitigate risk related to sterility assurance.
• Validate and qualify equipment and systems as related to sterilization both upon initial validation and requalification.
• Work under minimal supervision to provide sterility assurance oversight to commissioning and qualification activities, ensuring adherence to internal and external requirements.
• Act independently with minimal supervision to conduct sterility assurance studies.
• Assist with maintaining and revising validation procedures. 
• Assure that all validation is performed to conform to GRAM’s and cGMP requirements. 

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! On