Shire Lead Operator in Round Lake, Illinois

Job Title:

Manufacturing Lead Operator

{Shire Job Title: Manufacturing Lead (A)}





Supervisor's Title:

Supv, Manufacturing





Pay Groupings:



This section focuses on the main purpose of the job in one to four sentences.

The Manufacturing Lead 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. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas. The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. He/She fully understands the regulations and may make recommendations according to their interpretations. He/She is responsible for the successful transfer of new processes/methodologies into the manufacturing area.

Essential Duties and Responsibilities:

This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

  • Assist supervisor in organizing, scheduling and directing other team members.

  • Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, validation.

  • Involved in hands-on execution of manufacturing operations.

  • Ensure timely and accurate generation of process documentation. Review documentation.

  • Resolve issues related to equipment, process and compliance. Main troubleshooting/response person.

  • Investigate any process problems timely and provide documentation.

  • Participate on Continuous Improvement Teams and may serve in a leadership role.

  • Train and mentor other team members and monitor training for newer team members.

  • Assist with process/equipment validation and data analysis.

  • Assign other project work and/or involvement in teams to team members.

  • Represent the dept. in cross functional teams as necessary.

  • May perform other duties as assigned.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • In-depth process knowledge of related manufacturing techniques and specialties.

  • 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.

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

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

  • Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.

  • This position requires shift, weekend and holiday work. Overtime may be required 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

  • Must not be allergic to Cephalosporin drugs.

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.

Requires AA degree with 4-6 years experience or high school diploma with >6 years related manufacturing experience. Bachelor’s degree or working towards degree, 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.

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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.