Shire Lead Filling Operator - 3rd Shift in Round Lake, Illinois

Summary:

The Lead Filling Operator is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. They are expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. In addition to making routine revisions to documents, they may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex troubleshooting tasks and may even assist during the transfer of new technologies into manufacturing. They have sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

Essential Duties and Responsibilities:

  • Supports all local manufacturing operations

  • Supplies components, small parts, glassware, tubing, etc. to cell culture and purification areas

  • Operates general production equipment (such as parts washers, autoclave, stir plates, etc.)

  • Completes relevant paperwork following GDP/GMP guidelines

  • Manually 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 the production area to maintain in GMP fashion

  • Prepares media and buffer solutions

  • Assembles and operates filtration systems

  • Writes, revises and reviews pertinent documentation as appropriate

  • Trains and mentors junior level technicians

  • Troubleshoots process problems and responds to process alarms

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

  • Initiates and/or coordinates other process improvement projects

  • May perform other duties as assigned

Qualifications:

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

  • Good procedural writing skills

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

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

  • 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 ability to work effectively and efficiently in a team environment

  • This position requires shift, weekend and holiday work; Overtime may be mandated at times

  • The incumbent must work in a clean room environment wearing special garments; additionally, personal protective equipment must be worn due to safety requirements

  • Knowledge of basic chemical and biological safety procedures

  • May require immunization before performing work within the manufacturing area

  • Good computer skills

Education and/or Experience:

Requires AS/AA degree with 2-4 years of experience or high school diploma with 4-6 years related manufacturing experience

Physical Demands:

  • Must be able to lift, push, pull and carry up to 25 lbs.

  • In general, the position requires a combination of sedentary work and walking through the facility

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

  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment

  • Will work in a cold, wet environment

  • Must be able to work multiple shifts, including weekends

  • Must be able to work overtime as required

  • May be required to work in a confined area

  • Some 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.