Shire Senior Manufacturing Tech 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.

  • 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, and 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

Requirements:

  • Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.

  • Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.

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

  • 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 read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills.

  • Knowledge of chemical and biological safety procedures.

  • Good computer skills, knowledge of Microsoft Word and Excel.

  • 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.

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

Qualifications:

Experience in a regulated production

environment desirable:

 Bachelor’s degree in science /

engineering with 1+ years of or

 AA or equivalent and 6+ years of

experience or

 High School diploma with 8+ years of

experience.

Must have working knowledge of

scientific principles. Scientific or

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.

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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.