Description

Who we are:

At Dendreon, we're transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the disease.

If you're driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.

Core Values:

• Put Patients First: Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity: We commit to transparency, honesty, and always doing what's right.
• Build Trust: Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results: We are accountable to each other and deliver success together.

Job Summary: The Facilities Mechanic I is an integral member of a team responsible for assisting and performing building maintenance, equipment maintenance and metrology work for a cGMP compliant pharmaceutical research facility. In addition, this position will train to back-up their direct supervisor during vacations or unplanned leave.  This position is ideal for a sharp, mature, and responsible self-starter with career aspirations.

NOTE: This role requires on-site presence at our Seal Beach, CA location.

• Participate in activities involving calibration, validation, and metrology in areas such as temperature, pressure and time interval/rotation on incubators, refrigerators, freezers, centrifuges, fume hoods, biosafety cabinets, and other laboratory equipment.
• Performs routine building/office maintenance and repair activities.
• Assist with coordination between Facilities, vendors and building management to identify and respond to operational requirements.
• Assist with the implementation, revision, maintaining and review of company SOPs and policies.
• Performs Routine Safety Inspections.
• Support internal and external audit activities relating to GMP compliance.
• Responsible for completing all assigned compliance training.
• Support tracking and reporting of Facility KPI metrics. 
• Participate on a scheduled 24/7 on-call rotation and ability to get to our site at any hour day or night in a timely manner. The on-call assignment is typically 1 week (7 days) per month.
• Manage time appropriately and work with a sense of urgency.
• Cross-train to support departmental operational continuity during supervisor absences.

Scope:

• Performs routine assignments under general supervision while following established procedures and GMP requirements.
• Applies established procedures and techniques to complete assigned tasks effectively.
• Assists senior Facilities personnel with troubleshooting, maintenance activities, calibration support, and vendor coordination.
• Exercises sound judgment in resolving routine operational issues and escalating complex matters appropriately.
• Continues developing technical knowledge and facility maintenance skills within a regulated environment.

• Associate Degree in a technical discipline preferred.
• Experience working within a regulated GMP environment preferred.
• 13 years of general maintenance experience in a laboratory, manufacturing, or regulated environment preferred, or equivalent combination of education, training, and experience.
• Experience completing and documenting work orders using CMMS (BMRAM) or equivalent system preferred.
• Competent use of MS office applications and ability to learn specialized programs.
• Strong attention to detail with excellent written and oral communications skills.
• Self-motivated and able to function effectively within a team environment.
• Flexibility to take on additional duties and reprioritize as needed.

Working Conditions and Physical Requirements:

• Travel as needed to manufacturing sites, partners, and regulatory interactions.
• Limited use of laboratory equipment, chemicals and biological materials.
• Ability to sit or stand for extended periods of time. 
• Intermittent walking to gain access to work areas.
• Finger dexterity sufficient to use a computer and to complete paperwork activities.
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
• Ability to gown aseptically for work in a Clean Room environment.
• Hearing sufficient to communicate with individuals by telephone and in person.
• Duties may require handling chemicals and biological materials.
• May be required to work alternate shifts.
• Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Must be able to regularly lift 10 20 lbs, and on occasion up to 50 lbs.
• Ability to climb and work off ladders.
• Must have the ability to work around laboratories, manufacturing areas, and equipment, with potential exposure to blood, blood products, or OPIM (other potentially infectious materials), while utilizing required personal protective equipment.

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