Supervisor, Instrumentation
Location:
, California
Posted:
November 21, 2017
Reference:
R0015800
Essential Duties & Responsibilities
•Supervise instrument technicians who conduct calibrations of critical plant equipment on a regular basis to include, but not limited to Filling Machines, Lyophilizer, Capping Equipment, Packaging and support equipment. Provides secondary support to the operation and maintenance of manual and automated door systems, pumps and equipment, industrial control systems as responsibility assigned to Facilities Manufacturing Maintenance in both cGMP and non-cGMP areas.
•Responsible for supporting mechanics during manufacturing equipment repairs mechanical and electrical equipment as assigned with strict compliance to cGMPs and EHS regulations.
•Develop and manage performance of direct reports.
•Perform or support technical reviews, investigations and process improvement projects.
•Provide input into integration and validation of new equipment and process.
•Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies such as CAL OSHA and OSHA.
•Ensures personnel Training Plan execution and compliance. Attends required training, meetings. Interact with and oversee contractor/vendor work.
•Create Life Cycle documents (functional specifications, design specifications) and Standard Operating Procedures (SOPs) for Formulation/Finish, TOFX, Packaging and Mfg areas
•May perform other duties as assigned.
Qualifications
•Knowledge of cGMP manufacturing as it relates to a calibration program
•Calibration experience with pressure, temperature, flow, conductivity, pH is preferred
•Basic supervisory and leadership skills. Proven successful interpersonal and customer skills required.
•Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: Filling machines, process tanks, support equipment, analytical equipment, and CIP/SIP systems.
•Knowledge of basic chemical and biological safety procedures.
•Able to manage multiple priorities in manufacturing plant setting
•Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
•Must be able to read, write, and converse in English.
•Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
•Good computer skills, knowledge of Microsoft Word and Excel.
•Good interpersonal skills and be able to work effectively and efficiently in a team environment.
•Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
•Knowledge of clean room management.
•Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
•Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training, performance management, and self-service applications.
•Must have the ability to navigate electronic mail systems and intranet for communication purposes.
• Advanced word processing, spreadsheet and typing skills required.
•Job pace may be fast and Job completion demands may be high.
Education and/or Experience
Bachelor's Degree plus 3-6 years experience in Biotech maintenance or manufacturing, or AA Degree with 5-7 years of Biotech maintenance or manufacturing experience, or HS Diploma with 7-10 years of manufacturing experience. Minimum of 1-4 years of leadership experience. Scientific or engineering degree preferred.

Working Environment
•Must be able to work more than 8 hours a day or 40 hours a workweek as required.
•Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.
•Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
•The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
•May work in a cold, wet environment.
•May be exposed to sunlight and heat.
•May be exposed to dust, gases, and fumes.
•Possible exposure to cool/hot storage conditions.
•May be around moving equipment and machinery.
•May climb up and into large processing tanks for cleaning or inspection.
•May be working in a loud area that requires hearing protection and other protective equipment to be worn.
•May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
•Inside working conditions.
•Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
•Will work in a cold, wet environment and hot humid environments both inside and outside of facility.
•Will work around chemicals such as paint, flooring materials, refrigerants, alcohol, acids, buffers that may require respiratory protection.
•May be required to work or be assigned to a different shift as needed.
•May be required to travel for business reasons, e.g. training and meetings
•Will have interaction with other people.
•May be required to work 4 days a week 10 hour days.
•Pace may be fast and job completion demands may be high.

Physical Demand
•May be required to push up to 75 pounds.
•May be required to pull up to 75 pounds.
•May be required to balance occasionally.
•May be required to carry items frequently.
•May be required to climb frequently.
•May be required to use hand / finger feel frequently.
•May be required movement of head /neck frequently.
•May be required to grip and grasp frequently.
•May be required to use hearing occasionally.
•May be required to kneel frequently.
•May be required repetitive/sustained stooping and bending frequently.
•May be required to stand constantly.
•May be required to walk frequently.
•May be required overhead reaching occasionally.
•May be required to visually inspect frequently.


A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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