Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
This position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for testing, purification, and fill and finish for its biologic medications.
The Utilities Operation Technician is responsible for operate and troubleshoot utilities systems that support manufacturing process areas. Strict adherence to Standard Operating Procedures (SOPs), cGMPs, and Quality Standards in a Pharmaceutical Manufacturing facility are mandatory. Primary responsibilities include ensuring safe and efficient hands-on operation of utilities systems including but not limited to WFI, RO, PA, Alcohol, Boilers, Chillers, Cooling Towers, Wastewater Treatment Plant (WWTP) and related support equipment such as pumps, fans, valves, etc.
Perform daily utilities systems operations activities.
Ensure accurate documentation of urgent, critical alarms and triages activities through adherence to cGDPs.
Perform systems monitoring (watchstanding) and ensure proper response and communication through SOP adherence.
Assist with troubleshooting of utilities equipment issues including mechanical, electrical, metrology, or automation as needed.
Support equipment IQ/OQ/PQ/Validation startup activities.
Support Reliability Centered Maintenance (RCM) activities to include Condition Monitoring and Infrared Technologies.
Strict adherence to EH&S guidelines and policies required to ensure compliance to Georgia state, federal EPA, and OSHA regulatory agencies.
Maintain all mandatory training requirements current, ensuring compliance to site DP’s and job performance qualifications.
Maintain two-way performance dialogue with your Supervisor to ensure mid, annual, and PDP processes are completed in timely fashion.
Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem solving abilities.
Maintain a positive, professional, and customer oriented attitude.
Communicate concerns related to safe work practices, hostile work environment, sexual harassment, or any other type of employee misconduct directly to the Supervisor, Manager, or Human Resources.
May perform other duties as assigned.
Technical troubleshooting /problem solving skills are a must. Possess or have ability to gain knowledge with respect to the operation and maintenance of various Process Manufacturing systems.
Possess or have ability to gain verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess interpersonal skills.
Possess mechanical knowledge of equipment, using P&ID’s, equipment manuals, specifications, SOPs, and be able to use proper judgment when taking corrective actions during equipment malfunctions.
Possess or have ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Georgia requirements.
Must have the following personal attributes
Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Passion to innovate and drive for solutions.
Must display personal accountability for results and integrity.
Must display eagerness to learn and continuous self-improvement
Must have uncompromising dedication to quality.
Must have relentless focus on rapid and disciplined action
Must have respect for individuals and the diverse contributions of all.
Minimum Associates Degree (Engineering or Engineering technology desired) or a
Minimum of 3 to 5 years combination of education, training, and experience in a process equipment maintenance related environment.
May work in cold, wet environment.
May be exposed to sunlight and heat.
May be exposed to dust, gases, and fumes.
May be around moving equipment and machinery.
May climb up to and/or into large processing tanks for cleaning or inspection.
May be working in areas requiring hearing protection and/or other protective equipment (PPE).
May work around chemicals such as alcohol, acids, buffers, and may require respiratory protection (PPE)
May be required to frequently kneel, stand, and walk to inspect, evaluate, and/or perform described maintenance activities
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