Supervisor, Maintenance - Freeze Dry

Teva Sicor Pharmaceuticals is a global leader in the manufacture of generic injectable pharmaceuticals.  Now a member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs, TEVA Sicor has an excellent opportunity for a Supervisor, Maintenance - Freeze Dry.

 

Supervisory Responsibilities: Supervises the pharmaceutical Maintenance operation, which includes production, facility, and lyophilization to achieve reliable utilization of facility and/or production equipment through the use of documented preventative maintenance procedures. Reporting to this position would be Maintenance, Group Leaders, Technicians III, II, and On-Duty Operators.  Holds a responsibility for all freeze dry equipment mechanical operation, controls, electrical/electronic systems, and power systems.  Responsible for equipment electrical and mechanical installation, control system optimization, effective/efficient operation of the equipment along with advanced repairs, troubleshooting, and preventative maintenance of the equipment and systems. 

 

Responsibilities:

* Compliance with core values ? Teamwork, Honesty, Integrity, and Knowledge.

* Directly responsible for modifications and upgrading of equipment for a more effective operation.  May include equipment installation, electrical and controls, refrigeration, mechanical design, revalidation support, and troubleshooting of equipment.

* Proper budgeting of expenses, maintenance capital equipment requirements, and miscellaneous maintenance projects.

* Providing a communications conduit for the Production, Quality Assurance, and Engineering Departments in an effort to identify and evaluate repairs and modifications to facility and production equipment.

* Accountable for personnel development, salary administration, cGMP/SOP training, counseling, performance evaluation of assigned employees, safety performance, and conformance to all company and governmental standards and regulations.  Supports candidate selection process.

* Monitoring and reporting of daily performance of $40M of production and facilities equipment and systems.  Reports are to be issued on a weekly and monthly basis.  Directly accountable for the daily operation of equipment and its readiness for production.

* Provides advanced troubleshooting and maintenance support on technically sophisticated process machinery, facilities, and systems.

* Accountable for writing, updating, reviewing, proper performance of, and documenting Maintenance SOPs, PMs, policies, and procedures as outlined by Maintenance management.

* Responsible for the development of objectives and monthly reports and all communications both written and verbal to Engineering management.

* Proper change control and documentation procedures.  All procedures must be complied with to satisfy regulatory authorities during local, state, federal, and foreign agency audit.

Principle Responsibilities:

* Has a general responsibility for all refrigeration equipment mechanical operation, controls, electrical and mechanical installation, equipment optimization, effective/efficient equipment operation, electrical/electronic systems, and preventive maintenance.

* Supports basic ?hands on? training of less experienced technicians on SOPs, PMs, troubleshooting, and general preventative maintenance.

* Completes and understands training requirements as identified by the Maintenance Manager/Group leader and/or the GSP training department.  This includes all SOPs referring to the production or facilities equipment, maintenance documentation procedures, safety, cGMPs and equipment operational parameter SOPs.

* Responsible for understanding and review of the proper use of maintenance documentation, which is required under cGMPs.  Examples include: Maintenance Work Order system, the CSCR system, Preventative Maintenance Documentation forms, SOP documentation, and the use of Equipment Log Books.

* Responsible for coordinating projects with vendors and suppliers up to $20,000 in value.  These projects involve close coordination and supervision with the responsible Maintenance Group Leader, Supervisor, and Manager, along with the Engineering, QA/QC and Validation departments.

* Completes assignments and emergency repairs in a timely manner to reduce downtime and production delays.

* Expected to work with new equipment installation and start up, as well as write new and revise old SOPs.

* Has a good understanding of all pharmaceutical processes.  Uses initiative to work with a minimum of supervision and guidance.

* Is available for emergency callbacks as required and is flexible toward work hours including holidays or plant shutdown periods.

* Writes and performs CSCRs per SOP.

* Schedules and organizes work methods, procures materials and parts, maintains a file of equipment records and manuals.  Initiates and controls vendor interface, also writes, reviews and approves purchase requisitions for equipment requirements.

* Supervises the work of outside contractors when installing, repairing or investigating equipment within the facility.

 

 Requirements:

* Superior understanding of all Maintenance Technician skills.

* High School diploma or equivalent.  Completion of vocational courses in areas such as welding, mechanics, control systems, electrical, refrigeration, HVAC, or Lyophilization is desirable.

* Two (2) years technical schooling and five to seven (5-7) years experience as a technician, or one (1) year technical schooling and seven to ten (7-10) years experience as a technician involved with mechanical, electrical, electronics and PLCs, preferably in a pharmaceutical manufacturing environment.

* Experience in repair, installation, maintenance and modifications to freeze dry equipment.

* Excellent oral and written English communication skills are a must.  Good knowledge of computer skills and how to use for troubleshooting PLCs is required.

* Ability to use maintenance tools, precision instruments and testing equipment safely and accurately.  Has advanced mechanical and electrical troubleshooting skills.

* May be required to operate heavy equipment such as forklift.

* Good understanding of single and three phase power troubleshooting and maintenance techniques.

* Has expertise with other special skill sets needed to perform advance troubleshooting or maintenance. .

* PLC experience with troubleshooting and basic programming.

* Moderate to heavy physical effort consisting of bending, lifting, climbing on safety ladders, moving and installing heavy equipment.  Disassembly of equipment and some maintenance in awkward places and positions required.

 

* Able to gown according to aseptic gowning requirements.

 

* The Maintenance Supervisor must not have any known allergies or reactions to antibiotics. May be exposed to high temperature, dirty working conditions and high elevation when repairing some equipment.  Occasionally will be required to work outside.

 

* Experienced with and keeps abreast of regulatory requirements for facility and processes to ensure compliance to local, state, federal, and international regulations as required.

 

* Computer literate in contemporary software packages including MS Word, MS Excel, etc.

 

As a new member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.

 

TEVA Sicor offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company.  For immediate consideration, please visit www.tevausa.com.  Click Employment Opportunities, then Positions Available and search for Position # 4915.  You may also fax your resume to 949-458-8945.