Shire Manufacturing Trainer, IG - Filling & Packaging 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 Ophthalmic.

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 IG Filling and Packaging Department is comprised of two (2) groups that work closely together (including some cross-training) in order to fill, inspect, and package IG final containers.

The IG department responsibilities:

  • Filling group has responsibilities for the setup (cleaning and sterilization) of components and vessels as well as the entire vial filling process (vial washing, depyrogenation, and filing within an isolator).

  • Packaging group has responsibilities for the inspection of both empty vials (in preparation of filling) and product filled vials as well as the entire packaging line.

As these groups are responsible for the sterile preparation of components, the final filtration and filling of the product, inspection of both empty vials (in preparation of filling) and product filled vials as well as the entire packaging line, attention to detail and compliance to procedures is critical to ensure the manufacture of a safe, sterile, defect free product for our patients.

  • Learn and become trained on all processes within the IG Filling and IG Packaging Department, including SOP/Job Aid training and a basic knowledge of DeltaV, EBM, and PLC based control systems.

  • Perform production operations according to job aids and EBM, when not performing assessment

  • In working with Quality Assurance, lead the initial and annual requalification of all team members for filled vial inspection, including working with supervisors to schedule training, maintaining calendar to ensure team remains compliant on this critical process, providing all initial training, and completing and submitting all required documentation.

  • Provide hands on training for new team members or cross training opportunities to ensure they are qualified technicians and able to execute tasks independently. In addition, mentor Lead Technicians and Sr. Manufacturing Technicians to develop them into shop floor trainers. Provide oversight and documentation support for their training.

  • Maintain the training status of all IG Filling and IG Packaging employees and communicate to the supervisors to ensure the team is properly trained to execute the production steps.

  • Be a liaison with the technical training team to coordinate Onboarding training (NEO, Core, select training), resolve technical SABA issues, and support any issues from the shop floor manufacturing team.

  • In working with manufacturing management, develop and maintain training plans. Track progress and provide reports as requested.

  • Generate weekly training reports for missing requirements to ensure the department remains in a compliant state. Update Tier 1 and Tier 2 boards accordingly with the data.

  • Utilize the Shire Leadership Behaviors to create a culture of continuous improvement, both on the shop floor processes as well as the training systems.

  • When requested, create and/or revise SOPs, Job Aids, Knowledge Assessments, and Skills Assessment documents to support the department.

  • May perform other duties as assigned

Requirements:

  • Knowledge of cGMP manufacturing

  • Knowledge of basic pharmaceutical production equipment including but not limited to: CIP/SIP systems, valves and process tanks, autoclaves, vial filling lines, palletizers, incubators, and packaging lines.

  • 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.

  • Knowledge of basic chemical and biological safety procedures.

  • Good computer skills, knowledge of manufacturing systems (EBM, Delta V, RAM) and Microsoft Word and Excel.

  • Good interpersonal skills and be able to work 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.

  • This position requires flexible shift schedules to support all manufacturing shifts.

  • No make-up, jewelry, nail polish or artificial fingernails may be worn in the work environment.

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

Qualifications:

Requires a high school diploma or GED with 6+ years of related experience or an Associate’s or Bachelor’s degree in a scientific discipline or equivalent with 4+ years of related experience and demonstrated working knowledge of scientific principles. Filled Vial Inspection qualification / training will require a successful eye exam.

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.