The Computer System Validation Specialist will engage in the coordination of validation efforts for

computer systems, hardware, and software, especially in the lab setting, to ensure process quality at

NBR/NBS. The CSV will also be responsible for reviewing test results and identifying areas for

improvement and implementing changes along with ensuring the system and processes are compliant.

with GxP, GAMP and Code of Federal Regulations.

Role Responsibilities

• Work with QA management in development and implementation of efficient

software/computer validation program for GLP environment.

• Identify computerized systems validation needs through in-house assessments or by

coordinating needs assessments to be conducted by external team.

• Partner with business and validation team for site computer validation projects including but

not limited to creating computer system planning documents and testing protocols.

• Responsible for development of Software/Computer validations protocols and final reports as

well as to coordinate and perform activities per protocols

• Responsible for maintaining site Master Validation Schedule and periodic review of validated

systems.

• Assist QA in the process of auditing vendors of cGMP related software and hardware.

• Evaluate Vendor validations, adding company specific protocols as required to complete

validation

• Provide technical council on issues and concerns regarding validation plans and protocol

designs. Provide input on the design of the specifications and/or functional specification

requirements for equipment’s facilities and systems

• Train company as needed on SOPs

• Other duties as assigned.

Role Requirements

• Bachelor’s Degree in related field required.

• Minimum of 5 years of experience in Computer Systems Validations Computer System Validation Specialist

• Knowledge of GLPs (21 CFR Part 11) and other federal regulations relating to information

technology

• Good written and oral communication skills

• Advanced understanding of laboratory operations and data collection

• Ability to work effectively under time constraints

Behavioral Expectations

• Communication

• Critical Thinking

• Time Management

Special Requirements

• This role will spend approximately 80% of time in an office setting and 20% of time in the

laboratory. There may be exposure to animal pathogens and chemicals. There may be

handling of and/or exposure to animal tissues and zoonotic organisms.

• Ability to don and wear personal protective gear, including respirators.

Job Type: Full-time

Pay: $85,000.00 - $105,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 10 years
• 5 years

Schedule:

• 8 hour shift
• Day shift

Ability to commute/relocate:

• Muskegon, MI 49444: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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