Shire Engineer II in Social Circle, Georgia

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.

The Engineer is responsible for operational, maintenance and troubleshooting support for site utilities including but not limited to; RO and WFI systems, boilers, compressed air, chillers, alcohol distillation operations, HVAC, cooling towers and sanitary systems. This position will support reliability centered maintenance and TPM for all utility systems, including OEE and other reliability metrics. The Engineer will implement area improvements through strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility.

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 department to ensure reliable equipment operation. Participate in validation activities including documentation of IQ/OQ protocols, executions, and summary reports. Participate in the development and implementation of procedural Standard Operating Procedures (SOPs) and technical specifications (Design/Functional/System). Assist with improvement activities. These will include updating P&IDs, user and functional requirements specifications and equipment specifications,. Assist with 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. Support the planning and execution of start-up and validation by working in cross-functional teams. Assist in driving projects to completion and meet timeline and budget objectives. Maintain routine communication with Engineering Management to ensure needs are met. 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. 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. 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. Stay current with biopharmaceutical industry best practices and technologies. May perform other duties as assigned.

Excellent technical troubleshooting/problem solving skills are a must. Must have knowledge of various utility systems including HVAC, chillers, cooling towers, boilers, air compressors, RO and WFI systems and alcohol distillation operations. 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 P&IDs, equipment manuals, specifications, standard operating procedures, and be able to use proper judgment when taking corrective actions during equipment malfunction. Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.) Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. Has the ability to prioritize multiple tasks and work on multiple projects simultaneously. Must be a self-starter, detail oriented and able to work independently with minimal supervision. Must have computer skills (Word, Excel, BAS, Scada systems) Knowledgable of programmable logic controllers, DCS, instrumentation and controls. Display a positive, professional and customer oriented attitude. Must have the following personal attributes: Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. Must have passion to innovate and drive for solutions. Must display personal accountability for results and integrity. Must display eagerness to learn and continuously improve. Must have uncompromising dedication to quality. Must have respect for individuals and the diverse contributions of all.

  • Education and/or experience B.S. degree required in an Engineering discipline with the preference being Chemical, Environmental or Mechanical, with 0-8 years in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry.

  • Preferred experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry. 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.

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 at http://baxalta.com/assets/documents/eeocselfprint_poster.pdf

EEO is the law - Supplement at http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy at http://www.dol.gov/ofccp/pdf/EO13665PrescribedNondiscriminationPostingLanguageJRFQA508c.pdf

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.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

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.