Newly combined with Baxalta, Shire is now the leading global biotechnology company
focused on serving people affected by rare diseases and highly specialized conditions.
These diseases are often misunderstood, undiagnosed and life-threatening.
Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
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 Process Maintenance Technician
is responsible for providing operational, maintenance, and troubleshooting support for 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 maintenance of all Process manufacturing equipment including but not limited to Tanks, Mixers, Agitators, Centrifuges, Filter Presses, Filtration Skids, CIP Skids, Fill and Packaging equipment, and related support equipment such as pumps, fans, valves, etc.
- Perform daily work order activities per Planning/Scheduling.
- Ensure accurate documentation of PM, CM, and Emergent work order activities through adherence to cGDPs.
- Assist with troubleshooting of process 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.
- Perform assigned Metrology activities as assigned.
- Familiarity with Change Control, Site, and Divisional SOPs related to position and department are required.
- Procedural (JP's, HECP's, JHA's, etc.) revision's as necessary.
- 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 NFPA 70E electrical qualifications.
- Possess or have ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Georgia requirements.
- Must possess computer skills (Word, Excel, BAS, Scada, Electronic Mail, Intranet) to navigate, conduct searches, and complete on-line forms for purposes of training, performance management, self-service applications, and communication purposes.
- 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.
- High School Diploma required, Associates Degree in Engineering or Engineering technology desired.
- 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 celite that may require respiratory protection (PPE)
- May be required to frequently kneel, stand, and walk to inspect, evaluate, and/or perform described maintenance activities.
GB123 Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.