Validation Engineer

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

• Bachelor's Degree with 1+ years of cGMP experience (Pharmaceutical, Life Sciences industry cGMP environment) Master's Degree is a plus
• Experience in the qualification of cell therapy equipment and cGMP environment is a plus
• Excellent interpersonal skills with experience dealing with a diverse workforce
• Strong multi‐tasking ability in conjunction with proven organizational skills.
• Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
• Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.
• Able to quickly understand and learn new technologies
• Creative in problem-solving abilities, able to think outside the box to find solutions
• Self-motivated and self-starter, able to work independently with minimal supervision
• Must be proactive, results oriented, and have strong attention to detail
• Strong written and verbal communication skills (including technical writing skills)
• May be required to work in controlled or clean room environments
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting to 25lbs.
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
• Primarily office environment but will be required to enter laboratory or GMP process areas don proper gowning / lab coats or PPE such as safety glasses and shoes
• Ability to work safely and effectively when working alone or working with others

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 benefit package designed for unique Health & 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.