Shire Manufacturing Engineer I/II – Aseptic Filling and Packaging 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 position supports operations and process equipment in a new, state-of-the-art plasma purification facility that brings Shire additional capacity for testing, purification, aseptic filling, and packaging for its biologic medications.

The position will play a support role as an on-shift manufacturing engineering representative for specific unit operations. Initial support in this role will focus on support for aseptic filling and final packaging operations.

Candidates must have excellent verbal and written communication skills. This position will be responsible for assisting in developing, evaluating, and implementing cost-effective equipment improvements in a fast-paced cGMP, biotechnology environment to include creating and executing change control documentation. Additionally, this position will be involved in many direct manufacturing support aspects including: equipment troubleshooting and de-bugging, issue escalation and containment as issues arise on shift, hands-on execution support of manufacturing operations, supervisor assistance as needed on shift, and contractor and consultant supervision.

Essential Duties and Responsibilities

Support manufacturing equipment and processes to ensure daily shift activities are completed on schedule Support changeover and machine set-up activities to ensure they are performed correctly and in a timely manner Support the planning and execution of manufacturing activities by actively engaging in cross-functional teams Troubleshoot and identify atypical processing conditions and how to respond to them Constant calibration with area Manager(s) focusing on technical background of issue as well as consequences considered when making decision Coordinate necessary manufacturing resources and rally support groups to resolve production-related issues Determine Environmental, Health, and Safety (EHS) needs and risks Assist in driving projects to completion and meet timeline and budget objectives Author SOPs, training materials, Job Aids, Electronic Batch Management (EBM) process steps, and manufacturing risk assessments Support deviation investigations for root cause and to implement corrective actions Create or update technical specifications (Design/Functional/System) 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

Requirements :

Education and/or Experience :

  • Experience executing engineering projects and supporting manufacturing issues in a FDA-regulated manufacturing environment is strongly preferred.

  • Hands-on experience and knowledge of aseptic filling unit operations and equipment including: isolated vial filler, vial washer, depyrogenation tunnel, stopper processor and autoclave, utility systems (WFI/RO/clean steam/compressed gases/HVAC), vial visual inspection equipment, vial labeling equipment, vial cartoning and case packing equipment, and vision systems is strongly preferred.

  • Experience with pharmaceutical final package serialization systems is preferred.

  • Must be able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.

  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint).

  • Must have the ability to effectively act as a contributing member of a team for Engineering projects, coordinate contractors, and drive results.

  • Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)

  • Must possess basic knowledge of Delta V, PLC based process control systems, and Human Machine Interface (HMI) configurations.

  • Must possess basic knowledge of instrumentation and mechanical equipment such as controllers, indicators, control valves, PLC, analyzers, sensors, pumps 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 embrace working in a fast-paced, team-oriented, cross-functional environment.

  • A B.S. degree is required in an Engineering discipline with the preference being Chemical, with a minimum of 0-8 years of experience in an engineering role within the pharmaceutical, biotechnology, or other FDA regulated industry.

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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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.