Description 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 Ophthalmics. 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. Summary
This position is a support role within Utilities Engineering. The Engineer is responsible for oversight of operational, maintenance and troubleshooting support for environmental rooms, stability chambers, incubators and HVAC clean room support at the Shire Plant. The Engineer will serve as the lead for utilities engineering between manufacturing, automation, quality assurance, validation and operations. Essential Duties and Responsibilities
The Utilities Engineer will also be on-call at all times to respond to plant-wide emergencies and manufacturing needs.
- Collect, analyze and report data for use by the Engineering and Quality department to ensure reliable operation within each controlled environmental room.
- Participate in validation activities including documentation of IQ/OQ protocols, executions, and summary reports.
- Participate in the development and implementation of procedural Stand ard Operating Procedures (SOPs) or technical specifications (Design/Functional/System) .
- Point person for improvement activities. These will include updating P&IDs, user and functional requirements specifications and authoring equipment specifications,.
- Manage small-scale capital projects, creating scope of work, risk assessments, justification, cost estimates, implementing purchase order requisitions and funding requests.
- Perform standard facility engineering assignments. Select sound techniques to solve problems and make design recommendations under direction of manager. Assess results for application, validity and conformance to specifications. Recommend material and process specifications.
7. Support the planning and execution of start-up and validation by working in cross-functional teams.
8. Assist in driving projects to completion and meet timeline and budget objectives.
- Maintain routine communication with Engineering Management to ensure needs are met.
10. Must be familiar with plant and divisional SOPs as related to positional and department responsibilities.
- Review procedures and update them as necessary.
- Ensure a safe work environment is maintained through adherence to safety guidelines and policies.
13. Must follow safety rules and ensure compliance with GA state and federal EPA regulation and laws.
- Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standatrd Operating Procedures.
- Maintain a positive, professional and customer oriented attitude. Communicate any 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.
16. Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.
17. Stay current with biopharmaceutical industry best practices and technologies.
18. May perform other duties as assigned. Qualifications
1. Excellent technical troubleshooting/problem solving skills are a must. Must have knowledge of various utility systems including HVAC, chillers cooling towers and Buiding Automation System.
2. Possess very strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills. Have a basic knowledge of utility equipment, using blue prints, equipment manuals, specifications, standard operating procedures, and be able to use proper judgment when taking corrective actions during equipment malfunction.
3. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
4. Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
5. Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
6. Must be a self-starter, detail oriented and able to work independently with minimal supervision.
7. Must have computer skills (Word, Excel, BAS, Scada systems)
8. Knowledgable of programmable logic controllers, DCS, instrumentation and controls.
9. Display a positive, professional and customer oriented attitude.
10. Must have the following personal attributes: Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
11. Must have passion to innovate and drive for solutions.
12. Must display personal accountability for results and integrity.
13. Must display eagerness to learn and continuously improve.
14. Must have uncompromising dedication to quality.
15. Must have respect for individuals and the diverse contributions of all.
Equal Employment Opportunity
- Education and/or experience B.S. degree required in an Engineering discipline with the preference being Mechanical, with 8-10 years in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry. A minimum of 3 years experience executing capital projects is preferred.
- Must have experience with clean, black utilities and HVAC equipment used in the biopharmaceutical industry. Experience with Honeywell Enterprise Building Integration (EBI) integrated with HC900 Hybrid, OSI-PI plant historian and RtReports is preferred.
- Should also be knowledgeable with the following: cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmaceutical industry (e.g., WFI, RO water, compressed gases), clean-in-place (CIP) equipment and cycles, clean room design and operating principles.
- Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations. Basic knowledge of programmable logic controllers (PLCs) and instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required.
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.