PharmEng Technology is currently seeking a Validation Consultant for a project in Atlanta, GA. The position is available immediately conditional of a successful interview.
- Responsible for providing direct services to site Validation Department management, aiding to increase the throughput of qualification and validation activities through the department.
- Review site qualification and validation documentation for accuracy, technical soundness and compliance to both site and regulatory guidelines.
- Project will include support of chiller equipment, mechanical and computerized systems.
- Provide support for the development of user requirement and functional specifications.
- Support the generation and execution of all commissioning and qualification documentation related to demonstration batches, thermal studies, validation studies for equipment, facilities, utilities, engineering test runs, development studies, software validation and final reports.
- Recommends to management as to the acceptance and release of qualified systems.
- Actively participates during all phases of validation projects. Evaluates projects, provides technical information to others.
- Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues.
- Review various documentation and drawings to ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.
- Provide technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformances.
- Support, investigate and troubleshoot problems and determine possible solutions.
- Provide effective solutions for the management of system deviations and non-conformances.
- Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy)
- At least 7-10 years of applied technical experience in the pharmaceutical or biotech industries.
- Firm understanding of cGMP validation requirements / guidelines and current industry practice.