Validation Specialist
4 weeks ago
- Prepare IQ/OQ and /or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment such as Flow Cytometers, Cell Separators, Centrifuges, Cell processing equipment, clean utilities, Bioreactors, Automated Control Systems, etc.
- Execute IQ/OQ and /or PQ protocols
- Prepare final reports for executed protocols
- Prepare final reports for vendor IQ, OQ and/or PQ protocols
- Review of executed IQ/OQ/PQ protocols and raw data
- Perform periodic review/requalification of validated equipment, systems and cleanrooms
- Manage assigned projects to completion in accordance with established timelines, following-up on review/approval cycles to ensure deadlines are met
- Assembling validation related documents; and filing/archiving approved documents
- Maintaining electronic records.
- BS/BA in engineering or a related Science discipline
- 3-7 + years of validation experience
- Ability to use validation instruments such as Kaye Validator, Tachometer, Multimeter, etc.
- Thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11.
- Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem solving ability and teamwork are necessary.
- Ability to comfortably interact and clearly communicate with individuals at all levels of the organization to provide project updates and follow-up communication for review cycle management.
- Must be a dedicated self-starter with a high energy level and able to achieve results.
- Must have strong problem-solving and critical thinking skills, with a track-record of successful issue resolution.
- Good time management skills to manage and meet deadlines.
- Strong collaborative and influencing skills and ability to work well in a cross-functional, team environment.
- Good computer skills and Microsoft Office knowledge.
- Ability to multi-task team is essential.
- Flexible and able to adapt to company growth and evolving responsibilities.
- Highly organized, detail oriented, and ability to manage multiple priorities.
- Ability to perform the job under direct or indirect supervision
- Must have the ability to work in a team-oriented environment and with clients
- Must have the ability to work with specialized equipment
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