What are the responsibilities and job description for the Validation Engineer position at Cellipont Bioservices?
Job Description
Job Description
Bridging innovation to cure
Developing and manufacturing your cell therapies from benchtop to bedside
Job Summary
Cellipont Bioservices is growing, and we are looking for a Validation Engineer who believes in the bridge between client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level.
The Validation Engineer will be part of the Validation team and will participate in validation initiatives for our current and future cell therapy programs. This position plays a key role demonstrating the values, culture, and deliverables for the site.
The Validation Engineer in this role will be trained to support validation projects of medium complexity (equipment, utilities, facilities, processes, computerized systems, etc.) in areas such as executing validation approaches, qualification studies, documentation generation and review (protocols, risk-assessments, etc.), and execution alongside validation contractors. With support, they will collaborate with contractors and act as validation signatory representatives to review and approve validation lifecycle documentation for GMP use, accountable to management and regulatory agencies. Alongside and with guidance from the Validation management, this position will be part of establishing and maturing all aspects of the validation program required to maintain the cGMP facility for cell therapy.
This is an exciting position with great professional development opportunities with a quickly growing company. The ideal candidate has a strong understanding of CGMPs, is creative in their problem solving, and is flexible to accommodate shifting priorities in a fast-paced startup environment.
The Role
- Support GMP validation projects of low to medium complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources
- Oversee qualification activities in cGMP validation best practices
- As required, develop qualification and validation protocols, execute the associated studies, analyze the resulting data, and develop the final report
- Support validation deviation investigations and determine assignable cause alongside Validation Lead and contractors
- Review validation lifecycle documentation, including requirements, specifications, protocols, and reports
- Support the Validation Team in any required activities to support the development, execution, or improvement of the Validation program
- Understand the application of Data Integrity per 21 CFR Part 11
- Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulations
- Equipment qualification principles in a cGMP environment (IQ, OQ, PQ)
- Understanding of the validation lifecycle in GMP settings
- Knowledge of cGMP, GAMP, 21CFR part 11, GDP
- Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
The Candidate
Position Benefits
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 does not accept 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 because of an unsolicited agency or search firm referral. Thank you.
