Sr Associate Facilities & Eng Compliance

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-31903
Amgen is looking for a Senior Associate Facilities to join our team who will provide maintenance, leadership and technical expertise in support of facility equipment/systems, utility systems and production suites ensuring systems operate within designed parameters. Area of responsibility consist of multiple facilities, disciplines and clients. All work is to be completed to assure minimal impact to production while complying with all cGMP guidelines and Amgen policies and procedures.
Position Responsibilities:
Direct, plan and delegate tasks to personnel in daily operations, corrective action and preventative maintenance activities in a reliable and compliant manner
Manage, schedule and process all related cGMP documentation associated with maintenance operations
Support selection, training, evaluation, staff relations and development of staff assigned to area of responsibility in order to maintain a proficient group of technicians which can meet the needs of manufacturing
Develop and maintain an ongoing training program and maintain training records for all staff assigned to area of responsibility
Assist with development and maintenance of a working inventory control system for all spare parts requirements
Manage the development and revision of related Standard Operating Procedures (SOPs) and job plans for area of responsibility to assure all maintenance operations have SOPs developed for them
Interact with various support departments and/or outside vendors and provide full maintenance support to meet the needs of the manufacturing groups for all related equipment for the plant
Evaluate current maintenance procedures and make appropriate changes to optimize the maintenance program
Assure all corporate change control procedures are followed and Regulatory and QA are notified prior to the changes
Complete work in accordance with Good Manufacturing Procedures (GMPs), SOPs and Amgen polices and regulations
Participate in On-Call rotations for after-hours facility and Manufacturing support and work outside of established shift hours upon short notice
Basic Qualifications
Master's degree
Bachelor's degree and 2 years of Maintenance or Utilities Operations experience
Associate's degree and 6 years of Maintenance or Utilities Operations experience
High school diploma / GED and 8 years of Maintenance or Utilities Operations experience
Preferred Qualifications
5+ years of experience in a maintenance or utilities associated craft within a cGMP manufacturing facility
Computer skills, including Maximo, Windows, MS Word, MS Project and Excel
Interpret and revise electrical schematics, P&ID's, I/O wiring and panel drawings
Excellent verbal and written communication skills
Organizational skills
Advanced knowledge and familiarity of the Amgen Computerized Maintenance Management System (CMMS), or like system
Knowledge of pneumatic, mechanical, instrumentation, electrical and hydraulic fundamentals
Excellent reading and writing skills, along with advanced computer and typing skills
Ability to work in awkward locations and outside of normal shift times
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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