Shire Mfg. Systems Department Specialist - IG in Social Circle, Georgia

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.

The Department specialist position is responsible for executing and strictly adhering to cGMP, environmental health and safety guidelines, and any other related regulation which could apply. High level summary of expectations will include but are not limited to:

  • Support change control process. Initiate and close change controls in Trackwise as needed.

  • Support corrective and preventive actions (CAPA) implementation and data analysis.

  • Ensure timely and accurate generation of process documentation, and review documentation.

  • Write, revise and review pertinent documentation as appropriate.

  • Ensure that log books are reviewed and corrected in a timely manner.

  • Contribute toward routing SOPs and Job aids, associated to manufacturing processes, as needed.

  • Ensure EBM work orders are addressed.

  • Support material onboarding process.

  • Communication with support groups for key activities taking place on the floor.

  • Understand supplier/customer process streams and interdependencies.

  • Must possess the ability to work independently and effectively with peers, and display strong interpersonal and organizational skills.

  • Follow instructions for completion of job tasks.

  • Complete written documentation of work performed following GDP/GMP guidelines.

  • Support manufacturing operations.

  • Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS).

  • Support and participate in Quality and EHS GEMBA walks and continuous improvements teams.

  • Must have customer service and leadership attitude to take ownership of any problem.

  • Escalate issues or decision effectively.

  • Represent the department in cross functional teams as necessary.

  • Train and mentor other team members. Education and/or Experience :High school diploma or equivalent required. Associate degree preferred.Experience in a regulated environment desirable.Must have working knowledge of GxP principles.Minimum 2-5 years of experienceAt least 2 years experience with a focus on pharmaceutical, food industry, and/or laboratory equipment, troubleshooting & repair within a cGMP environmentAt least 1 year experience in a clean room or GMP/regulated manufacturing environmentMust be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills.Must be able to read, write and converse in English.

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

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

  • May require immunization before performing work within the manufacturing area.

  • Must demonstrate importance of working in a regulated environment.

  • Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet.

  • Must have the knowledge and ability of using MS Office software (Word, Excel and PowerPoint).

  • Must have and display the following personal attributes:  Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

  • 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.

Must be able to work multiple shifts, including weekends.

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.