Shire Production Supervisor - Pharma (1st Shift) in Round Lake, Illinois

SUMMARY:

The Production Supervisor position is responsible for implementing and supervising all activities in the production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply; focus is on optimization in the use of raw materials, equipment and personnel in producing quality products; monitors and controls labor and capital expenditures; may assist in developing budgets; recommends manufacturing policies, procedures and programs.

RESPONSIBILITIES:

  • Provide guidance, support, direction and leadership through positive interactions with all associates during daily operations, primarily in Filling

  • Provide a positive and equitable working environment emphasizing the values of Caring, Inclusive, Innovative, Proactive and Transparent

  • Supervises the day-to-day production, safety, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines, quality, GMP and FDA standards

  • Interviews, hires, coaches, motivates, develops and disciplines staff; conducts annual performance reviews for all direct reports; assists in setting performance objectives and development plans; monitors progress

  • Reviews, approves, and manages documentation for batch and system records; assists in release of product for distribution; assists in meeting product release time goals

  • Emphasizes training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations

  • Develops and implements performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality; implements changes as needed based on assessments

  • Performs/leads technical reviews, investigations and process improvement projects; provides manufacturing input into integration and validation of new equipment and processes

  • Resolves technical, material and cGMP problems that may impact project deadlines; provides guidance and troubleshooting assistance as needed during a deviation in the process

  • Represents the company during FDA inspections; provides information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs

  • Lives and breathes the Shire Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an excellent Manager of Self and Others.

REQUIREMENTS:

  • BS degree in a scientific or engineering discipline with 3-5 years of manufacturing experience or AA degree with equivalent manufacturing experience and 4-6 years of supervisory related experience required

  • Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment

  • Strong problem solving skills

  • In-depth process knowledge of related manufacturing equipment and processes

  • Strong skills in managing multiple priorities in a manufacturing plant setting

  • Ability to analyze and interpret scientific and statistical data

  • Strong professional writing skills and ability to prepare technical reports

  • Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry

  • Strong assessment and troubleshooting skills

  • Ability to respond to detailed inquiries, and present information to groups and senior management

  • May be required to supervise multiple groups/shifts

  • Good computer skills

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 around observing conditions in 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

  • 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, 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.