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Aseptic Filling Process Engineer

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.
The position will support the aseptic vial filling process equipment in a new, state-of-the-art plasma purification/filling facility that will bring Shire additional capacity for testing, purification, and fill and finish for its biologic medications.
The position will play a leadership and support role as an Engineering representative for specific unit operations as part of the Filling/Packaging areas. This position will be responsible for developing, evaluating and implementing cost-effective equipment improvements in a fast-paced cGMP, biotechnology environment. This position will be involved with numerous phases and activities including: start-up, de-bugging, optimization, commissioning, validation, conformance lots, routine manufacturing, contractor and consultant supervision and creating and executing change control documentation.
Essential Duties and Responsibilities
1.Work independently with minimal supervision to execute all facets of projects.
2.Manage equipment system start-up and commissioning with minimal assistance, including identifying needed automation changes.
3.Support the planning and execution of start-up and validation by working in cross-functional teams.
4.Drive projects to completion and meet timeline and budget objectives
5.Create or update written Stand Operating Procedures (SOPs) related to project assignments.
6.Create or update technical specifications (Design/Functional/System) related to project assignments.
7.Supervise contractors and other personnel on project and activities.
8.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.
9.Stay current with biopharmaceutical industry best practices and technologies
10.May perform other duties as assigned.
Requirements:
Education and/or Experience :
+ Must have hand-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) and facility design.
+ Must have excellent organizational, verbal and written communication skills; 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) and MS Project.
+ Must have the ability to effectively lead/support Engineering projects, coordinate contractors, and drive results.
+ Must possess basic knowledge of core aseptic processing principles
+ 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.
Education and/or experience B.S. degree required in an Engineering discipline with the preference being Chemical or Mechanical, with 5-15 years of experience in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry (Position level commensurate with experience). Should also be knowledgeable with several of the following: sterile filtration, steam and VHP sterilization, 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) and controls is preferred.
_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.
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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.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.


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