Shire SR Utilities Engineer - Clean Water Systems 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 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.

Summary

The Utilities Engineer is responsible for oversight of operational and troubleshooting support for the clean utilities system distribution with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Systems include Purified water pretreatment (RO generation), Water for Injection (WFI), Clean Steam and Clean Air.

The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and reliability engineering.

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 Operations department to ensure reliable operation. Responsible for the design and operation of Water for Injection, Clean Steam, Clean Air Generation and Clean water distribution systems. Responsible for controlling approach of utility system to define interlocks and simultaneousness usage. Provides technical expertise for the design and/or commissioning phases associated with utility/facility systems. Provide guidance for support personnel and helps drive development of PM programs. Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the clean utilities system. 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), technical specifications (Design/Functional/System) and updating P&IDs. Manage small-scale capital projects, creating scope of work, risk assessments, justification, cost estimates and implementing purchase order requisitions. Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion and meet timeline and budget objectives. Must be familiar with plant and divisional SOPs as related to positional and department responsibilities. 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 Standard Operating Procedures. 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. Will perform other duties as assigned.

Requirements:

Excellent technical problem solving skills are a must. Candidate should be able to read and interpret P&ID drawings. Knowledge of CIP/SIP, clean room or classified area design/requirements. Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops. Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is required. Maintains the compliance of cGMP utility operations through initiating, executing and closing change records through the management of change process. Reviews drawings and documents produced by external groups for utility systems. Provides input into the validation of equipment and associated utilities through protocol review. Assist operations technical validation staff in the execution of validation protocols. Provides technical support to operations and manufacturing. Provides technical assessments for investigations, discrepancies, validation and change control. Performs equipment and system engineering studies, research/evaluate equipment components, review and modify equipment operation as a result of troubleshooting. Performs process design for facility projects, capacity expansions, equipment upgrading and replacement. Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry. Must 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), CIP equipment / cycles and operating principles. Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations. 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. Display a positive, professional and customer oriented attitude. Must be able to navigate, conduct searches, and fill on line forms on Personal Computer for the purposes of training and performance management applications. Must have the ability to navigate electronic mail systems and intranet for communication purposes. 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 respect for individuals and the diverse contributions of all.

B.S. degree required in Chemical or Mechanical Engineering with 8-10 years in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.

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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.