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Senior Validation Engineer job in The Woodlands

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Cellipont Bioservices jobs

The Woodlands Cellipont Bioservices


1) --- TO VIEW EMPLOYER PROFILE and JOBS LIST --- Click the Name Link or Logo
Job Posting Date:  04/20/2024
Employer Name:  Cellipont Bioservices
Job Position Type:  Full-time Regular
Job Ref. #:  920090
Employer Type:  For-Profit Employer
Job Overview Video: 
Industry:  Biotech Industry
Job Skills Category:  Engineering-BioScience
Quality Assurance
Regulatory-Any Type

2) --- JOB LOCATION (FOR THIS ROLE) --- CLICK "Show on map" LINK
Onsite-Remote Status:  Onsite Position
Texas Region:  Southeast Texas
City:  The Woodlands
State:  Texas - TX
Map - Work Location: 
9501 Lakeside Blvd, The Woodlands, TX 77381, USA (Show on map)

3) --- WORK SCHEDULE INFO & SPECIAL CONDITIONS
Travel Requirements:  No Travel
Days X Hours per Week:  5days X 40hrs
Work Shift:  DAYS / 1st SHIFT
Work Week Format:  Weekdays Primarily
Work Days-Primary:  Mon-Fri
Work Hours-Primary:  8am-5pm

4) --- HEALTH COVERAGE BEGINS DATE - PTO & JOB PERKS - INCENTIVES INFO
Health Coverage Begins:  Employer Hasn't Provided Info Yet
Paid Time Off:  Employer Hasn't Provided Info Yet
Job Perks / Incentives:  Flex Hrs. Start-End

5) --- JOB CLASSIFICATION & COMPENSATION INFO
Compensation Type:  Salary
Compensation Range:  Salary $100k - $150k Range
Background Check:  Background Check Required

6) --- JOB DESCRIPTION & REQUIREMENTS

 

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


THIS JOB APPLIES DIRECTLY TO THIS EMPLOYER
ref: (920090) 27 days ago
Applied = 0
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