Job description

Primary Responsibilities

• Support computer system validation projects related to authoring and executing specifications and validation documentation for laboratory and manufacturing systems.
• Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, GxP, local and corporate policies).
• Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.
• Requirements related to business use, data integrity, security, access, safety must be considered.
• Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan. Prepare validation summary reports for executed protocols. Author security administration and system support standard operating procedures, and audit trail review work instructions as appropriate.
• Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Work with System Owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures. Facilitate a continuous improvement culture within the Manufacturing and Lab areas supported.
• Investigate and resolve Deviations, CAPA investigations and other potential issues.
• Responsible for the delivery of all lifecycle deliverables for single and multi-user Computerized Systems.
• Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.

Qualifications

• Proven experience in a regulated environment within areas of responsibility is required.
• Minimum of 7 years in the Life Sciences industry.
• Knowledge of 21 CFR Part 11.
• Must maintain excellent working knowledge of pharmaceutical regulations (e.g., cGMP's, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g., OSHA, etc.) related to laboratory environment and system applications.
• Ability to work on multiple concurrent project initiatives.
• General understanding of lab and manufacturing processes.
• Effective problem solving and analytical skills to resolve operational problems.
• Excellent written and verbal communication skills.
• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
• Strong collaboration with colleagues at all levels.
• Demonstrated success in influencing without authority.
• Strong customer service and teamwork oriented.
• Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
• Highly flexible, adapting to changes in priorities, requirements and processes is required.

Education

• BS/BA required in Computer/Electrical Engineering or another relevant scientific field.
• 5+ years or equivalent relevant experience

Job Type: Full-time

Pay: $50.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Cranbury, NJ 08512: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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