“Bridging Innovation to Cure”
Developing and Manufacturing your cell therapies from benchtop to bedside.
Cellipont Bioservices is looking to recruit a Senior Validation Engineer to join our growing team in The Woodlands, TX.
The Senior Validation Engineer will work in an FDA-regulated clean room environment, this position is responsible for the validation of bioprocess equipment and GMP utilities. The Senior Validation Engineer is critical to our patients as this role is responsible for the commissioning of new facilities and equipment.
The Role
- Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility.
- Project based work will be in 3 main areas: Equipment Qualification, HVAC/Clean Room Qualification, and Temperature Mapping (Kaye Validator and/or AVS)
- May also develop Validation Master Plans, Validation Project Plans and Project Schedules as needed.
- Oversees the timely completion of all validation documentation, including coordination of contractor activities.
- Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable.
- May interact with internal clients and external vendors on equipment/process requirements.
- Support the maintenance of the validation program for facilities and equipment.
- Support changes through the provision of necessary validation documentation and change control activities.
- Support the regulatory defense of validation protocols and summary reports during external and internal audits.
- Develop and support continuous improvement initiatives for the validation of equipment, facility, utility, and control systems.
- Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures. Collect and analyze data to make data driven recommendations/decisions.
- Participate in equipment failure investigations.
- Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality, and Facilities Engineering.
- Maintain up-to-date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies.
The Candidate
- 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)
- Experience in Commissioning and Qualification activities as it relates to new facility preferred.
Position 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
“At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our “family” approach ensures you will get the mentorship you need to develop a satisfying career here!”
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Interested candidates should Apply Here.