The Davis Companies are partnering with a leading medical device manufacturing company in the Atlanta area to hire a high level Validation Engineer. The Validation Engineer will plan and perform activities concerned with equipment and process validation (design, review, execution and approval of installation, IQ/OQ/PQ protocols and final reports). They will also assist with regulatory documentation.
This is a direct hire role with a salary range of $115-125K.
- Perform equipment installation and operation qualifications (supporting new process changes or complex equipment implementations) through protocol generation, execution, and final report preparation.
- Perform process validations related to process changes or complex equipment implementations through protocol generation, execution, and final report preparation.
- Provide project validation oversight for new equipment implementations and process changes.
- Coordinate with the equipment users to specify the requirements.
- Coordinate with the vendors and Purchasing to ensure that all possible validation deliverables are evaluated and potentially purchased.
- Coordinate with other departments to ensure that validation activities (from equipment qualification through process validation) are appropriately planned to coincide with the overall project implementation.
- Define process and equipment validation policies and develop procedures to accomplish and document projects.
- Develop and implement new process equipment validation approaches requiring integration of new technological advances.
- Apply specialized scientific, engineering and validation knowledge in a creative way to a broad range of difficult process equipment validation problems.
- Initiate risk analysis and gap analysis to identify, understand, challenge, and develop process requirements and controls through qualification and validation efforts.
- Develop to level of process expert and act as technical resource to cross-departmental functions to respond to processing issues, safeguard product quality, provide technical training to operations, implement improvement initiatives, and investigate product/process-related problems in manufacturing and packaging.
- Maintain knowledge base relative to QSR, ISO, and FDA regulations including an understanding and familiarity with regulatory requirements, guidelines, and expectations for validation.
- Assist with preparation of regulatory filings, answering questions from regulatory agencies, and presentations of materials in regulatory inspections.
- Participates in FDA inspections, ISO audits, and customer audits of the plant quality system as related to validation activities.
- Minimum of BS in Engineering, Science or related technological field is required.
- 3+ years manufacturing related validation experience in the medical device industry required.
- Extensive knowledge and experience with QSR, ISO and FDA regulations including an understanding and familiarity with regulatory requirements, guidelines and expectations for validation.
- Experience with equipment, process and product validations. (IQ, OQ, PQ)
- Experience with managing multiple projects while working in a team environment
- Experience in participating in regulatory inspections and presenting or defending validation documentation.
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.