Shire Manufacturing Tech IV in Van Nuys, California

The position 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 IV 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. He/she may make routine revisions to Standard Operating Procedures (SOPs) and perform complex troubleshooting tasks or assist during the transfer of new technologies into manufacturing. He/she will organize and lead production activities. When the Manufacturing Lead is absent, the Manufacturing Tech IV will be fully accountable and involved in all production processes when in an interim Lead Operator role, When acting as an interim Lead Operator, the incumbent acts as a delegate to the Supervisor/Manufacturing Lead and may conduct departmental activities in their absence. Due to business need, employees may be required to work overtime and/or support operations on an alternate shift Manufacturing Tech IVs are expected to set the example for all other Shire employees as his/her team members observe the behavior of their leadership and interpret that behavior as acceptable. He/She must display the appropriate conduct, compliance, cleanliness, and culture of Shire while promoting Shire’s primary leadership behaviors.

Essential Duties and Responsibilities

  • Support all local manufacturing activities in Plasma Operations

  • Receive plasma shipments

  • Process plasma shipment documentation

  • Clean production area per cGMP

  • Participate on Safety and Continuous Improvement Teams and may serve in a leadership role.

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

  • Perform manual dispositioning of plasma shipments

  • Prepare plasma shipments for delivery to and from off-site storage facilities

  • Complete relevant paperwork following cGMP/cGDP guidelines and operate in compliance with the FDA, OSHA, and other regulatory agencies

  • Write, revise, and review pertinent documentation as appropriate

  • Troubleshoot process problems and respond to process alarms

  • Initiate and/or coordinate other process improvement projects

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

  • Operate powered industrial trucks for material handling (i.e. reach truck and rider pallet jack)

  • Perform plasma shipment receiving operations

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

  • May perform removal of hazardous waste

  • May assist Manufacturing Lead and Supervisor with managing manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor.

  • May assist Supervisor/Manufacturing Lead in organizing, scheduling and directing other team members.

  • Participate in the training and mentoring of team members on the manufacturing floor.

  • Participate in Initiate and/or coordinate other process improvement projects.

  • Drive performance of team members by promoting a positive work environment emphasizing respect, responsiveness, and results.


  • 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

  • Knowledgeable in Microsoft Excel, Word, and PowerPoint.

Education and/or experience

Requires high school diploma or GD with 4+ years related work experience, or AA or higher with 2+ years related work experience. Mechanical, electrical, instrumentation, or control systems repair experience preferred for mechanical special skills role.

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.

  • Will be exposed to warehousing and manufacturing areas at +5°C and -20°C or colder

  • Will be exposed to human blood plasma.

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 around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.

  • Will work in a cold, wet environment.

  • Must be able to work multiple shifts, including weekends.

  • Must be able to work overtime as required. (only for non-exempt positions)

  • 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.

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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.