Description 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. Summary
The position will lead and support the start-up and commissioning of 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 role as the Engineering lead/representative for specific unit operations as part of the project. Post-licensure, 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 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. 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 junior level engineering 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.
GD123 Qualifications Qualifications
- 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. Aseptic isolator startup is desirable.
- 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.
- Should 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 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, with a minimum of 5-8 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 aseptic filling equipment, sanitary design principles and materials of construction used in the biopharmaceutical industry. 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 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.
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Pay Transparency Policy 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.
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.