Shire Production Operator - Filling (ALL SHIFTS) in Round Lake, Illinois

SUMMARY:

The Fill Room Operator is responsible for executing all fill room activities at Shire's Round Lake, IL manufacturing facility, while strictly adhering to cGMP, GDP, environmental health and safety guidelines, FDA regulations and any other related regulations which could apply; fully participates in both departmental projects and any quality working teams which may be applicable; under general direction of lead technician and the overall direction of the supervisor, responsible for hands-on execution of all activities in production area; applies technical knowledge to perform complex troubleshooting tasks and may assist during transfer of new technologies into manufacturing; organizes and leads production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Supports all Shire Round Lake's pharmaceutical manufacturing operations in a clean room environment

  • Operates production equipment such as filling machines, filter integrity testers, parts washers, small autoclaves

  • Complete relevant documentation/paperwork, following GDP/GMP guidelines

  • Cleans all portable equipment and small parts

  • Participates on Continuous Improvement Teams

  • Receives and distributes supplies into the production area as necessary

  • Performs daily cleaning of production area and maintains in GMP fashion

  • Assembles and operates filtration systems

  • Trains and mentors new employees and contractors

  • Troubleshoots process problems and responds to process alarms

  • Works with other groups such as maintenance to ensure preventative maintenance is done

  • Initiates and/or coordinates other process improvement projects

  • This position may require shift, weekend and holiday work; mandatory overtime may be required at times (typically 2 8-hour Saturdays per month)

  • Embodies the Shire Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an Excellent Manager of Self and Others.

  • May perform other duties as assigned

QUALIFICATIONS:

  • Must be willing and able to work set hours on assigned shift: 1st Shift: 7:00am-3:30pm Monday through Friday; 2nd Shift: 3:00pm-11:30pm Monday through Friday; 3rd Shift: 11:00pm-7:30am Sunday night through Friday morning.

  • Must be willing and able to work mandatory overtime, typically two 8-hour Saturdays per month

  • Must have good written and verbal communication skills and strong understanding of cGMP regulations

  • Must have good procedural writing skills

  • Familiarity with pharmaceutical production equipment including but not limited to autoclave, parts washer, and CIP/SIP

  • Must be able to read and follow detailed written instructions in English

  • Must be able to apply quantitative analysis to analyze process performance

  • Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement

  • Good interpersonal skills and demonstrated ability to work effectively and efficiently in a team environment

  • Must work in a clean room environment wearing special garments and required personal protective equipment due to safety, GMP and FDA requirements

  • Knowledge of basic chemical and biological safety procedures

  • May require immunization before performing work within the manufacturing area

  • Good computer skills

  • Must have 20/25 vision or better within arm’s length

  • Must NOT be colorblind

EDUCATION AND/OR EXPERIENCE:

Requires AS/AA degree with 2-4 years of pharmaceutical manufacturing experience or High School Diploma/G.E.D. with 4-6 years of related manufacturing experience

PHYSICAL DEMANDS:

  • Must be able to lift, push, pull and/or carry up to 30 lbs.

  • Repetitive motions with hands, wrists, turning head, bending at knees and waist

WORKING ENVIRONMENT:

  • Must be able to work in controlled environments requiring special gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body

  • Make-up, jewelry, contact lenses, nail polish and artificial fingernails ARE PROHIBITED in the manufacturing environment

  • May work in a cold, wet environment

  • Must be able to work multiple shifts, including weekends

  • Must be able to work overtime as required, including Saturdays

  • May be required to work in a confined area

  • Will be exposed to Clean Room and cool/hot storage conditions

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, gender identity, 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/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.