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.
Education & Experience :
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.
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