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Cellipont Bioservices · 1 week ago
Senior Validation Engineer
The Woodlands, TX
Full-time
Hybrid
Senior Level
5+ years exp
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BiotechnologyHealth Care
Insider Connection @Cellipont Bioservices
Responsibilities
Generate operational protocol(s), qualification IQ, OQ, PQ protocols, and SOPs for equipment/systems/processes.
Develop Validation Master Plans, Validation Project Plans, and Project Schedules.
Oversee timely completion of validation documentation and coordinate contractor activities.
Support maintenance of validation program for facilities and equipment.
Support changes through provision of necessary validation documentation and change control activities.
Support regulatory defense of validation protocols and summary reports during audits.
Develop and support continuous improvement initiatives for validation of equipment, facility, utility, and control systems.
Provide hands-on support to manufacturing areas for problem solving and process improvements.
Collect and analyze data to make data-driven recommendations.
Participate in equipment failure investigations.
Maintain up-to-date knowledge of validation requirements and procedures.
Qualification
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Required
B.S. in Engineering or Science discipline
5 or more years of validation experience in a GMP environment
At least 1 year of direct experience in a CDMO environment
Knowledgeable and/or exposure to biological manufacturing processes, such as cell and gene therapy, vaccine, cell banking, and aseptic fill finish
Experience with qualifying QC Analytical equipment and Facilities/Utilities
Working knowledge of Kaye/Amphenol data logging equipment (Validator, AVS)
Preferred
Experience in Commissioning and Qualification activities as it relates to new facility
Benefits
Opportunities for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross-functional exposure to other areas within the organization
Robust benefits package designed for unique Health and Wellness needs, including coverage for your furry family members
401K strong employer match
Tuition Reimbursement
Employee Referral Bonuses
Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
Gain experience in the cutting-edge cell therapy space
Company
Cellipont Bioservices
Cellipont Bioservices is a cell therapy CDMO that specializes in cell therapy development and small-to-large batch production.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-11Acquired· by Great Point Partners
Leadership Team
Deborah Wild
President and Chief Executive Officer
Will James
Chief Financial Officer
Recent News
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