Shire Manufacturing Technician 1 in Van Nuys, California

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, Ophthalmic, 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.

This position reports to Swing (2nd) shift. This shift schedule is Monday to Friday 2:00 PM to 10:30 PM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift.

The Manufacturing Associate is responsible for the receiving, dispositioning, and storage of human blood plasma in preparation of plasma production runs in the Teardown department. He/she will perform basic troubleshooting tasks for the Automated Plasma Dispositioning System (APDS) Sorting Line. Under the direction of a Supervisor or Lead Operator, the Manufacturing Technician I is responsible for executing all processes in production, while strictly adhering to cGMP, environmental health and safety guidelines and other related regulations that could apply. He/she is expected to fully participate in both departmental projects and any quality working teams when applicable. He/she is expected to keep an updated record of training. Due to business need, employees may be required to work overtime and/or support operations on an alternate shift.

Essential Duties and Responsibilities

  • Support all local manufacturing activities in Plasma Operations

  • Clean production area per cGMP

  • Participate on Continuous Improvement teams

  • Perform plasma loading, carton opening, carton disposal, and MES functions to support APDS sorting line operations based on Teardown plasma schedule

  • Segregate plasma units to be processed with an “On Hold” or “Quarantine” status

  • Follow basic safety rules, SOPs, cGMP, work rules and company policies.

Qualifications

  • Must have good written and verbal communication skills and understanding of cGMP regulations

  • Good procedural writing skills

  • Must be able to read and follow detailed written instructions

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

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

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment

  • May require weekend and holiday work.

  • Must wear personal protective equipment (PPE)

  • Knowledge of basic chemical and biological safety procedures

  • May require immunization before performing work within the manufacturing area

  • Must have basic computer skills

Education and/or experience

Requires AA degree or high school diploma with 0-2 years of related manufacturing experience

Physical Demands

  • Must be able to lift, push, pull and carry up to 50 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.

  • Must be able to work overtime as required.

  • May be required to work in a confined area.

  • Some Clean Room and cool/hot storage

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.