Computer Systems Validation Specialist

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:

This Computer Systems Validation Specialist supports computer systems validation activities as well as other qualification and validation activities at Grand River Aseptic Manufacturing.

Non-Negotiable Requirements:

• Bachelor of Science or Masters of Science in Chemical/Biomedical Engineering, Pharmaceutical Engineering, Chemistry, or IT. Degree may be exchanged with appropriate work experience.
• A minimum of 2 years CSV related experience in an API, pharmaceutical, or biotech industry.
• Knowledge of 21 CFR Part 11 principles and Annex 11 Regulations.
• Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations is a must.
• Knowledge of the basic principles of validation across multiple disciplines, for example, equipment, utilities, software, and cleaning and process validation, but main focus is computer system validation.
• Understanding and knowing the level of information in the set of documents: VMP, VPP URS/FRS, Risk Assessments, CS/DS,IOPQ,RTM,VSR.
• Understanding SDLC process.
• Understanding the principles behind JIRA and Confluence.

Preferred Requirements

• Basic understanding of industry standards and best practices associated with computer system validation such as GAMP 5 and ASTM E2500 is preferred.
• Experience with MasterControl preferred.

Responsibilities Include (but are not limited to):

• Responsible for preparing appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities. Main focus is on CSV related projects.
• Act independently with minimal supervision to conduct validation duties.
• Utilize risk assessments to identify critical areas for validation and generates test scripts accordingly that are in relation to IQ,OQ, PQ, etc..
• Collaborate with cross functional teams within the company to ensure successful validation of systems.
• Review change control documents, work orders, document change requests for assessing impact on validated systems.
• Proactively and regularly communicate with the project team to update on validation status.
• Follow and maintain good practices with regards to processes and /or internal conditions leading to an aseptic environment.
• Complete periodic reviews on validated computer systems and address identified concerns/Follow up with the designated teams to complete the periodic reviews within the robust timelines.
• Participate in the review and approval of system change controls, deviations, and CAPAs related to computer systems.
• Facilitate vendor interactions, including drafting or reviewing the CSV related activities 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 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.