Principal Process Engineer - Fractionation

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 lead and support the start-up and commissioning of process equipment in a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for testing, purification, and fill and finish for its biologic medications.
This position will be responsible for developing, evaluating and implementing cost-effective equipment improvements in a fast-paced cGMP, biotechnology environment. This includes numerous phases and activities of the project including: start-up, de-bugging, optimization, commissioning, validation, conformance lots, routine manufacturing, contractor and consultant supervision and creating and executing change control documentation. In addition, this position will be responsible to support commercial operations as a system expert.
Essential Duties and Responsibilities
Work independently with minimal supervision to execute all facets of projects.
Manage equipment system start-up and commissioning with minimal assistance, including identifying needed automation changes.
Support the planning and execution of start-up and validation by working in cross-functional teams.
Drive projects to completion and meet timeline and budget objectives
Create or update written Stand Operating Procedures (SOPs) related to project assignments.
Create or update technical specifications (Design/Functional/System) related to project assignments.
Supervise contractors and junior level engineering personnel on project and activities.
.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.
+ Must have a demonstrated track record of successfully executing engineering projects and supporting manufacturing issues in a FDA-regulated manufacturing environment. Green field experience is desirable.
+ Must have hand-on experience and knowledge of biotech unit operations i.e. filtration, centrifugation, process vessels, buffer prep, solids addition, CIP/COP), utility systems (WFI/RO/compressed gases/HVAC) and facility design.
+ Must have working knowledge of Delta V automation system
+ 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 Engineering projects, coordinate contractors, and drive results.
+ Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.), as well as be experienced applying project management methodology.
+ 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 :
Education and/or experience B.S. degree required in an Engineering discipline with the preference being Chemical, with a minimum of 5-8 years of experience in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry. A minimum of 2 years? experience executing capital projects is preferred. Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry. 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.
_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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