Job Details:
Computer Validation Engineer – Process Controls
- Support all aspects of the Validation Life Cycle in Manufacturing from design through operation and improvement as required. Creates new validation approaches for new equipment; processes, or to align procedures and standards.
- Administer and create the Computer Validation Program for the site, including the author/review/approval of Computer Validation Master Plans, Process Control Installation/Operational Qualification protocols, and alarm acceptance testing protocols, computer acceptance protocols and maintenance of computer systems in accordance with corporate and departmental procedures.
- Provide key technical review for the site with respect to SOP development and provide technical input for change control in order to assure that site needs are addressed, and compliance and industry standards are incorporated.
- Review or revise Standard Operating Procedures (SOP’s) as required.
- Responsible for developing the site requalification plan and strategy, execution and implementation.
- Streamline testing requirements while maintaining regulatory and corporate compliance.
- Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments, periodic reviews.
- Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
- BS/BA in science, chemical engineering or life sciences
- 5 years pharmaceutical experience in validation preferably with knowledge of secondary process equipment.
- 5 years of Computer Systems Validation experience with a focus on controls.
Rob McCabe / Liberty Personnel Services / 484-238-1965 / www.libertyjobs.com / rob@libertyjobs.com