Validation Engineer - Katalyst Healthcares & Life Sciences
Hopkinton, MA 01748
About the Job
Roles & Responsibilities:
- Perform equipment and system validations.
- Develop, review, and approve accurate documentation, as required in cGMP operations.
- Provide responsive customer support with emphasis on customer satisfaction.
- Work in a collaborative team environment and interact with other support groups such as Manufacturing, PD, QC, MS&T, and Quality Assurance.
- Assist with HSE, Qualification and Maintenance activities as needed.
- Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing commissioning/qualification activities.
- Assist with drafting of accurate commissioning/qualification procedures and training documents/tools
- Ensure assigned re-qualifications (RQs) are completed on-time.
- Provide QC lab validation review (LEQ) as required.
- Review Validation protocols, reports, data, plans, change controls, etc., as required.
- Provide technical assistance to less experienced technicians/engineers.
- Work as part of a team to ensure that commissioning/qualification activities are completed on-time and correctly.
- Work as part of a multi-disciplinary team for Commissioning/Qualification using a science and risk-based approach.
- Manage medium to large size commissioning/qualification projects and change control-based qualification activities.
- Develop Validation Plans for validation projects.
- Perform SOP revision, review, and approval.
- Generate deviations, CAPAs, perform investigations and root cause analysis.
- Work with Quality Assurance on the revision of validation documents (e.g. Master Plans, Requalification program)
- Present and defend validation studies during regulatory inspections and internal audits.
- Bachelor's degree (or equivalent) in engineering/science
- 4+ years' experience hands-on experience in Biotech, Pharmaceuticals or Medical Device operations, including protocol development and field execution.
- Working knowledge of Validation Lifecycle Approach (DQ, IQ, OQ, PQ, PV, and RQ)
- Knowledge of applicable US and worldwide regulatory requirements (e.g. GMP, GDP, ICH)
- Ability to develop and/or review protocols using design documents and user requirements.
- Experience with chamber temperature mapping, tubing welders, and Biosafety cabinets are a plus.
- Ability to manage medium to large size commissioning/qualification projects.
- Ability to perform thorough statistical analysis of validation rest results.
- Excellent technical writing and verbal communication skills
- Ability to Investigation/troubleshooting system/testing failures
- Ability to read/interpret engineering drawings (e.g. P&IDs, PFD's)
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
Source : Katalyst Healthcares & Life Sciences