The Engineer - Computer Systems Validation will perform all or some of the following Job description:
- Provide oversight to all aspects of validation, principally computer systems validation, equipment, and facility validations
- Assure that documented evidence exists to provide a high degree of assurance that the operation and maintenance of all systems are consistently reproducible, meet the required standards and specifications, and all computerized systems comply with laid down requirements
- Review and approve validation protocols, validation reports and assure appropriate support documentation is included
- Author computer system validation documents
- Respond promptly to customer needs, resolve technical and tactical operational problems within the scope of the position and draft and/or review documentation such as plans, scripts, and qualification protocols
- Serve as a member of project teams for new equipment, facility upgrades and validations
- Lead and / or participate in local and regional teams in CSV project initiatives and be the CSV Subject Matter Expert for all FDA, Corporate or other regulatory inspections
- Lead and / or participate in investigations to ensure thorough root cause analysis is conducted and CAPA implementation is effective and sustained
- Monitor validation systems and implement corrective actions as necessary. Minimum requirements • Bachelor’s Degree in Engineering or a Scientific discipline and 4 years of experience in pharmaceutical computer system validation.
- Demonstrated knowledge and technical understanding of pharmaceutical unit operations
- Demonstrated knowledge in two or more of the following: pharmaceutical computer systems, equipment, facilities, utilities and/or automation
- Demonstrated knowledge of cGMPs and Good Document Practices (GDPs)
- Detail orientated, organizational, technical writing and presentation skills
- Must be a team player prepared to lead, work in and embrace a team-based culture
- Ability to communicate and collaborate with technical and management staff within Manufacturing, Engineering, Technical Services and Quality
- Project management skills, including creating / managing project budgets, resources (internal and external) and schedules
- Ability to lead and direct complex assignments with little or guidance
- Ability to provide solutions to a variety Validation issues
- Ability to manage multiple projects at one time
- Ability to deal successfully with difficult personalities
- Execute small capital projects and preventative action plans.
Novartis - 2 years ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...