Job description
About Harrow
At Harrow, we are working hard to help our customers navigate the realities of the healthcare market by providing innovative medications and solutions that address both clinical and economic needs. We need exceptionally talented, bright, and driven people to get there. If you would like to help us build a quality culture organization trusted by healthcare professionals across the country, this is your chance to join us.
Position Description
The
Computer System Validation Engineer is responsible for driving the CSV activities at our drug manufacturing facilities in Ledgewood, NJ. This position is responsible for developing, performing, implementing, and managing the Computer System Validation program for the site to ensure compliance with regulatory agency requirements, internal company standards, and current industry practices. This is a salaried, full-time position.
Position Responsibilities
- Performs and leads Computer System Validation projects related to authoring and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment, and methods according to 21CFR Part 11 and ISPE GAMP 5 Validation Life Cycle.
- Responsible for generating documents including System Requirement Specification (SRS), System Impact Assessment (SIA), Data Integrity Assessment (DIA), Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail.
- Generate validation protocols, and summary reports in line with Computer System Validation Plan, 21CFR Part 11, and ISPE GAMP guidelines and regulations.
- Generate and maintain site Computer System Validation procedures in line with Site Validation Master Plan.
- Review and execute Computer System Validation protocols to ensure compliance and adherence with cGMP and ISPE GAMP guidelines and regulations.
- Write risk assessments and useful test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Validation Master Plan.
- Provide input into deviations, CAPAs, and Change Controls to ensure that equipment and systems remain validated.
- Communicate requirements and challenges to the Director of Validation to initiate appropriate actions.
- Serve as a subject matter expert (SME) for SCV during client audits and regulatory inspections.
- All other duties as assigned.
Qualifications
- Bachelor’s degree in computer science, engineering, life sciences or related technical field.
- 4+ years of relevant CSV experience in a dynamic, fast growth pharmaceutical or biopharma industry manufacturing environments.
- Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing.
- In depth knowledge of FDA guidelines, 21 CFR Part 11 compliance requirements and ISPE GAMP 5 guidelines.
- Ability to work effectively under pressure, handle multiple projects and meet deadlines
- Ability to review and analyze data.
- Possess and demonstrate excellent oral and written communication skills.
- Possess excellent proactive problem-solving analytical and negotiation skills and solid critical thinking.
- Well organized, detail-oriented and possess ability to multi-task.
Work Environment/Physical Demands
- The employee is occasionally required to sit; talk; hear; stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch
- The employee must occasionally lift and/or move up to 25 pounds
- Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus
AAP/EEO Statement
Harrow believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.
Harrow is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
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