Location: Phoenix, Arizona, United States
The Operator II (Equipment) participates in the manufacture of Abraxane in complete accordance with all cGMP, SOP, and Batch Records. The operator II (Equipment) ensures production equipment is cleaned, prepped, set-up, operational and maintained in validated conditions to meet production timelines as directed by supervision. He/she works in a compliant, efficient, effective and safe manner and effectively manages resources to maintain production goals and efficiencies. This position may require overtime, shift work, and flexibility in scheduling of “set” shift hours at times, based on production or department needs. This is a 2nd shift position.
• Obtains and maintains aseptic gowning qualification.
• Ensures production equipment is cleaned, prepped, set-up, operational and maintained in validated conditions to meet production timelines as directed by supervision.
• Performs preventive inspections, assists with periodic and incidental maintenance and repair of aseptic production equipment, as required.
• Assists Maintenance in maintaining records of repairs of equipment and purchases of equipment or parts as necessary.
• Assists Maintenance in purchasing and maintaining adequate inventories of supplies and replacement parts. Reconcile parts inventories, reduce and receive inventories and keep accurate records
• Assists Engineering in the design, specification and/or procurement of new equipment.
• Works with outside contractors and vendors as necessary.
• Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively by completing forms, reports, logs, and record of equipment and batches.
• Communicates effectively and professionally with peers, following detailed instructions/procedures, and demonstrating strong teamwork.
• Continuously updates job knowledge by participating in training opportunities
• Identifies potential production issues and works quickly with area supervision to address them.
• Trains/Coaches peers on technical tasks specific to the operation of production equipment.
• Executes departmental projects, including process optimization, communicating status to internal stakeholders, as directed
• Completes other tasks, as assigned
• Requires a High School diploma or equivalent, Technical Certification/College degree preferred
• Must have good understanding of cGMP requirements
• 3 year work experience in a regulated, manufacturing environment; 2 years in an environment with cGMP; 1 year in a clean room manufacturing environment
• Prior experience in set-up and maintenance of production equipment preferred
• Must have an appropriate level of understanding of manufacturing processes, systems operations, and equipment
• Must have strong problem solving skills
• Must possess strong mechanical aptitude
• Must possess basic math and science skills and ability to use a computer
• Requires a demonstrated ability to read, understand, interpret, and apply technical writing and instruction
• Equivalent combination of experience / education is acceptable.
Requires proficiency in basic MS Word, Outlook, Excel
Requires ability to deal appropriately with regulatory agencies
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Requires strong organizational and time management skills
Requires strong critical reasoning and decision making skills
Requires strong teamwork and facilitation skills
Requires ability to interpret / write general business documents
Requires ability to interpret / write technical documents
Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance
Requires ability to solve routine problems
Level of Supervision
Requires direct supervision
Impact of decisions
Impacts one department
Impacts multiple departments
Requires uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment
Requires pre-employment screening (respirator physical, lift test, etc…)
Requires safety alertness due to work around hazardous equipment and conditions
Requires participation in annual health monitoring due to handling of hazardous substances
Requires ability to push, pull, reach, balance and/or lift up to 50 lbs
Requires set hours by Supervision
Requires ability to stand for extended periods of time
Requires ability to wear specific PPE (full face respirator, clean room “bunny” suit, PAPR)