We are seeking a highly motivated individual to join us as a Validation Engineer at the TCF05 Commercial Facility in Urbana, Maryland. You will work with the Engineering, OT/IT, QC and Manufacturing teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Associate Director of Validation within the Facilities and Engineering organization.
Responsibilities (include but are not limited to):
- Create and execute commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ), including identification and resolution of exceptional conditions;
- Provide computerized system, equipment, utility system and facility commissioning and qualification guidance and strategy execution during project planning and development phases;
- Participate in periodic reviews of the facility, utilities and equipment;
- Review technical documentation including protocols & summary reports and Commissioning, Qualification & Validation (CQV) lifecycle documentation, other testing, and validation SOPs;
- Perform temperature mapping and other miscellaneous validation activities;
- Support contractors performing equipment and utility system commissioning, qualification, and validation;
- Support Computerized System Validation (CSV) protocol development and execution;
- Support process and method transfer validation activities, as necessary by manufacturing and Quality Control labs;
- Report status and progress of qualification activities or projects to the Leadership team;
- Perform investigations and implement corrective actions related to CAPAs and deviations;
- Develop or Review technical specifications documents necessary for generation and/or execution of CSV and CQV lifecycle documentation;
- Support the execution of engineering projects;
- Other duties as assigned.
- Master’s Degree and 2+ years of experience in science or related field in the biotechnology, pharmaceutical, medical device industry or related analytical/micro lab operations OR
- Bachelor’s Degree and 4+ years of experience in science or related field in the biotechnology, pharmaceutical, medical device industry or related analytical/micro lab operations OR
- Associate Degree and 5+ years of experience in science or related field in the biotechnology, pharmaceutical, medical device industry or related analytical/micro lab operations OR
- High School Degree and 6+ years of experience in science or related field in the biotechnology, pharmaceutical, medical device industry or related analytical/micro lab operations
- BS or MS degree in Computer Science & Engineering, Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biotechnology or Life Sciences
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices;
- Analytical and Microbiological laboratory equipment and software qualification is essential;
- Familiarity with equipment commissioning and qualification in a cGMP environment (IQ, OQ, PQ) as well as utility and facility validation experience is preferred;
- Foundational understanding of Computerized System Validation (CSV);
- Read and interpret drawings such as PFDs, P&IDs and electrical schematics;
- Working knowledge of scientific and engineering principles related to the biopharma industry;
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development;
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions;
- Ability to think critically with demonstrated troubleshooting and problem-solving skills;
- Ability to function efficiently and independently in a dynamic, fast paced environment;
- Self-motivated and willing to accept temporary responsibilities outside of initial job description;
- Well-developed computer skills and fluent with Microsoft office applications;
- Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment;
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities and business needs.
Does this sound like you? If so, apply today!
* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.
To discover more about Kite please visit our Career Site at https://www.kitepharma.com/careers/careers-at-kite