Bellicum Pharmaceuticals, located in the Houston Medical Center, is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.
Due to our continued growth, there is an excellent opportunity for an experienced GMP Equipment Specialist. Reporting to the Equipment Supervisor, this role will be responsible for ensuring the compliance of all controlled equipment used in Bellicum’ s manufacturing process and equipment used to support the manufacturing process, including but not limited to, final drug product storage, shipment, QC equipment and Process Development equipment.
• Maintain equipment to support GMP manufacturing ensuring all equipment complies with Bellicum Standard Operating Procedures and Policies.
• Execute equipment validations, calibrations and preventative maintenance.
• Escort and aid equipment vendors and contractors when they are onsite performing maintenance and repair. This includes working in an ISO 7 classified cleanroom environment requiring gowning in cleanroom suits, bouffant caps, facemask, gloves, goggles and gloves.
• Manage equipment per the Bellicum equipment life cycle program to including tracking from purchase to equipment retirement.
• Coordinate on-site calibration and maintenance services with third party providers.
• Responsible for reviewing equipment calibration and preventive maintenance documentation and labeling provided by vendors or contractors.
• Responsible for the generation of equipment and system installation, operation and performance qualifications protocols and reports.
• Responsible for reviewing executed installation, operation and performance qualifications protocols and reports.
• Responsible for writing, reviewing and revising technical SOPs and policies for all applicable equipment use, care and maintenance.
• Responsible for training end users on the maintenance of equipment and time of use calibration.
• Identify and participate in the procurement of applicable equipment.
Other responsibilities Include:
• Manage equipment and facility monitoring system including documentation and investigation of alarms.
• Respond to equipment and facility monitoring system alarms.
• Participate in the management of deviation documentation, investigation reports and CAPA program.
• Other duties as required.
• Time will be split between office setting and working in an ISO 7 cleanroom suite requiring full cleanroom gowning including cleanroom suits, bouffant caps, facemask, gloves, goggles and gloves.
• There will be possible exposure to blood, body fluids and or tissue
• Must be able to lift 50 pounds
• Technical proficiency with equipment common to cell therapy processing including but not limited to Sepax, CliniMACS, centrifuge, biological safety cabinet, controlled rate freezer, cryogenic storage dewars, LN2 and CO2 manifolds, incubator, balance
• Experienced in MS Word, Power Point and Excel.
Bachelor’s degree in healthcare, engineering or science related field.
Minimum of 1 year of professional experience in GMP manufacturing, pharmaceutical or cellular therapy.
We invite you to check us out www.bellicum.com. We offer a competitive Total Rewards program including stock options and employer paid benefit premiums.
We thank you for your interest in Bellicum and your submission. Please be advised that only those candidates selected to move forward will be contacted.