Description:

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.

 

Basic Qualifications:

  • 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

 

Preferred Qualifications:

 

  • 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

About Gilead / Kite:

At Gilead, we’re committed to creating a healthier world for everyone – no matter the challenges ahead of us. For more than 30 years, we’ve pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It’s what’s next. At Kite, we are focused on the cure. Our singular focus is on cell therapy — the use of genetically modified immune cells programmed to target tumors — which we believe has the potential to change the way cancer is treated. Through our focused efforts and important industry and academic partnerships, we have been able to advance our industry-leading pipeline of chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates with the goal of treating both hematological cancers and solid tumors.

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