Sr. Operator, Aseptic (Equipment) - 1st, 2nd or 3rd Shift Job

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Date: Jun 13, 2014 Location: Phoenix, Arizona, United States Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. POSITION SUMMARY The Sr Operator (Equipment) participates in the equipment set-up, manufacturing, and production of Abraxane in complete accordance with all cGMP, SOP, and Batch Records. He/ She ensures proper systems and equipment are in place to meet production timelines as directed by supervision. He/ She leads around process improvement projects and programs. He/she creates a compliant, efficient, effective and safe environment, effectively troubleshooting to maintain production goals and efficiencies. The Sr Operator monitors others work, and ensures proper execution of production activities within the aseptic environment and it’s supporting areas. This position may require overtime, shift work, and flexibility in scheduling of “set” shift hours at times, based on production or department needs. ESSENTIAL FUNCTIONS • Obtains and maintains aseptic gowning qualification. • Ensures proper systems and equipment are in place to meet production timelines as directed by supervision • Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively by completing forms, reports, logs, and record of equipment and batches. • Ensures area/facility cleanliness, equipment cleanliness, and proper operation and functionality of all equipment, hardware, tanks, and tools within the Aseptic Operations facility. • Troubleshoots technical issues, coordinates repairs with maintenance, and communicates status to supervision. • Works with maintenance to minimize downtime, coordinate work scheduling, and ensure equipment is maintained in proper operating and validated conditions. • Communicates effectively and professionally with peers, following and providing detailed instructions/procedures, as well as demonstrating strong teamwork. • Communicates with supporting departments to ensure materials and components are available to meet production timelines as directed by supervision. • Perform preventive inspections, assist with periodic and incidental maintenance and repair of aseptic production equipment as required. • Assist Maintenance in maintaining records of repairs of equipment and purchases of equipment or parts as necessary. • Assist Maintenance in purchasing and maintaining adequate inventories of supplies and replacement parts. Reconcile parts inventories, reduce and receive inventories and keep accurate records • Assist Engineering in the design, specification and/or procurement of new equipment. • Work with outside contractors and vendors as necessary. • Continuously updates job knowledge by participating in training opportunities • 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 • Qualifies as a departmental trainer • Completes other tasks, as assigned EDUCATION/EXPERIENCE REQUIREMENTS • Requires a High School diploma or equivalent, Technical Certification/College degree preferred • Must have good understanding of cGMP requirements • 5 years 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 strong aseptic technique and process understanding • Requires a demonstrated ability to read, understand, interpret, and apply technical writing and instruction • Requires a demonstrated proficiency I training/coaching • Equivalent combination of experience / education is acceptable. Computer/Software Skills Requires proficiency in basic MS Word, Outlook, Excel Compliance Knowledge Requires ability to deal appropriately with regulatory agencies Requires general knowledge of cGMP, OSHA, DEA, USP and EP Requires detailed knowledge of cGMP, OSHA, DEA, USP and EP General Competencies 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 develop others, delegate and motivate Requires strategic thinking and ability to work independently Written Communication Requires ability to interpret / write general business documents Requires ability to interpret / write technical documents Training Skills Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance Requires strong presentation development and delivery skills Problem Solving Requires ability to solve routine problems Requires ability to solve routine and complex problems Level of Supervision Does not require direct supervision Impact of decisions Impacts one department Impacts multiple departments Impacts multiple departments and sites Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. *LI-MG1 Qualifications Requires a High School diploma or equivalent, Technical Certification/College degree preferred Must have good understanding of cGMP requirements 5 years work experience in a regulated, manufacturing environment; 2 years in an environment with cGMP; 1 year in a clean room manufacturing environment Req ID: 14001409 Primary Location: United States-Arizona-Phoenix Job: Manufacturing Organization: Abraxis Bioscience Schedule: Regular Shift: Standard Employee Status: Individual Contributor Job Type: Full-time Job Level: Day Job Travel: No Job Posting: 2014-05-15 00:00:00.0
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USA
Manufacturing

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