- 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.
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Validation Engineer
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The Lykan Bioscience Hold Hopkinton, United StatesWHO WE ARE · RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomousl ...
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Belcan Marlborough, United StatesValidation Engineer · Job Number: · Category: Test Engineering · Description: Job Title: Validation Engineer · Pay Rate: Up to $66.67/hr DoE · Location: Marlborough, MA · ZIP Code: 01752 · Start Date: Right Away · Job Type: Contract · Keywords: #ValidationEngineeringJobs ...
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Pyramid Consulting Marlborough, United StatesImmediate need for a talented Validation Engineer (Rockwell/PlantPAx). This is a 06+ Months Contract opportunity with long-term potential and is located in Marlborough, MA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID:(phone ...
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Primary Talent Partners Marlborough, United StatesPrimary Talent Partners is searching for a VALIDATION ENGINEER to join our client's team in Marlborough, MA . This role will be a 6-month, full-time, W2 contract role with a potential for extension and/or conversion. · Our client prefers candidates that can work a hybrid schedule ...
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Pyramid Consulting Marlborough, United StatesImmediate need for a talented · Validation Engineer (Rockwell/PlantPAx) . This is a · 06+ Months Contract · opportunity with long-term potential and is located in · Marlborough, MA(Onsite) . Please review the job description below and contact me ASAP if you are interested. · ...
Validation Engineer - Hopkinton, United States - Katalyst Healthcares and Life Sciences
