What are the responsibilities and job description for the Equipment and Process Validation Engineer position at Katalyst Healthcares and Lifesciences?
Job Description:
Primary Responsibilities:
Qualifications:
Preferred Qualifications:
Education:
- The Validation Engineer will support a facility-wide validation review and remediation initiative within a regulated manufacturing environment.
- The consultant will perform periodic reviews of manufacturing equipment, processes, and selected QC laboratory systems to confirm that each system remains in a compliant and validated state.
- Responsibilities will include reviewing legacy validation packages, comparing existing documentation against current procedures and risk requirements, conducting gap and risk assessments, identifying deficiencies, and recommending or completing required remediation activities.
- The consultant will draft and revise validation plans, protocols, risk assessments, qualification documents, and final reports; execute qualification or validation protocols when required; document discrepancies; and ensure identified gaps are tracked through closure.
- The role will primarily involve detailed documentation review and technical writing, with additional responsibility for protocol execution, report preparation, change documentation, and collaboration with Engineering, Manufacturing, Quality, and laboratory personnel.
Primary Responsibilities:
- Conduct periodic validation reviews for manufacturing equipment, processes, utilities, and selected QC laboratory systems.
- Review legacy equipment qualification and process validation documentation for completeness, accuracy, and continued compliance.
- Compare existing validation packages against current SOPs, regulatory expectations, and system risk profiles.
- Perform gap assessments and risk assessments to identify deficiencies in the current validated state.
- Develop remediation plans and complete assigned corrective validation activities.
- Draft, revise, and execute IQ, OQ, PQ, process validation, and related qualification protocols as applicable.
- Prepare validation plans, risk assessments, protocols, summary reports, and supporting technical documentation.
- Review executed protocols for completeness, accuracy, data integrity, deviations, and required follow-up.
- Support deviation resolution, change control, management-of-change activities, and documentation updates.
- Work with Engineering, Manufacturing, Quality, Automation, and laboratory personnel to collect technical information and resolve documentation gaps.
- Maintain organized, inspection-ready documentation within an electronic quality management system.
- Manage assigned reviews independently and communicate project status, risks, and obstacles to site leadership.
- Complete approximately one comprehensive periodic review or assigned system area per month, depending on complexity.
Qualifications:
- t least two to three years of equipment qualification, process validation, or manufacturing validation experience; three to five years is strongly preferred.
- Experience working in a pharmaceutical, biotechnology, medical device, or similarly regulated manufacturing environment.
- Hands-on experience with equipment qualification and process validation, including IQ, OQ, PQ, and validation lifecycle documentation.
- Demonstrated experience performing periodic reviews, validation assessments, gap assessments, or risk assessments.
- Experience reviewing legacy validation documentation and determining whether equipment or processes remain in a compliant validated state.
- Strong protocol-writing, technical-writing, document-review, and report-writing skills.
- bility to interpret SOPs, specifications, risk documents, validation protocols, engineering records, and executed test results.
- Strong attention to detail and the ability to identify inconsistencies, missing information, compliance gaps, and documentation deficiencies.
- Working knowledge of cGMP requirements and validation practices within regulated manufacturing.
- bility to work onsite five days per week in Virginia.
- bility to manage assigned work independently while collaborating with cross-functional site personnel.
Preferred Qualifications:
- Experience with regulated liquid processing, liquid handling, filling systems, or controlled filling operations.
- Pharmaceutical aseptic filling or IVDR medical-device manufacturing experience.
- Experience qualifying manufacturing equipment such as filling equipment, process skids, automated equipment, or related production systems.
- Familiarity with QC laboratory instrumentation qualification or periodic review.
- Experience with MasterControl is preferred; experience with TrackWise, PLM platforms, or another electronic QMS is also acceptable.
- Experience supporting change controls, management-of-change records, document revisions, and validation remediation.
- Experience working on overdue periodic-review backlogs or facility-wide validation-remediation projects.
- Familiarity with current risk-based validation and qualification practices.
Education:
- bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Biology, Life Sciences, or a related technical discipline is preferred. Candidates with an equivalent combination of relevant education, technical training, and substantial industry validation experience may also be considered.