Shire Manufacturing Technician I in Thousand Oaks, California

This position reports to Shift 1 Days and works a 4-10 hour shift schedule: Wednesday through Saturday from 0600 to 1630. Due to business need, on select occasions employees may be required to work overtime and/or support operations on an alternate shift.

The Manufacturing Technician I is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. The Manufacturing Technician I is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. All of the specific requirements presented in this job description are applicable to the functional area in which it resides.

Responsibilities:

  • Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

  • Responsible for Room sanitization, wrapping up components, operating autoclave, performing CIP/SIP of tanks, small parts washing

  • Clean and sanitize manufacturing and associated support areas.

  • Responsible for monitoring bioreactors and respond to alarms in all Cell Culture Suites.

  • Responsible for monitoring the skids and respond to alarms in all Purification Suites.

  • Record bioreactor, chart recorder readings, alarm response related to the bioreactor, skid performance, inoculums and emergency response during blackouts.

  • Conduct documentation review

  • Participate in Quality Working Teams and Continuous Improvement Teams

  • Conduct visual inspection of needles and assemble needle packs.

  • Load/Unload materials to conveyors and packaging carousel.

  • Responsible for Bio-decontamination and appearance of all Manufacturing Production areas, Bulk Formulation, Aseptic filling, Sterility Test room, Final Container Drying and Preparation Production rooms.

  • Prepare solutions in portable mixer.

  • Operate production equipment such as pH meter and autoclaves.

  • Monitor department equipment for proper operation.

  • Stock department supplies

  • Handling and Removal of Hazardous Waste

  • Basic Computer Skills

  • May perform safety and cGMP inspections or observations.

  • Ensure compliance with SOP/cGMP and cGDP requirements.

  • May assist in training of new employees.

  • May assist in updated/revising SOP’s.

  • Complete relevant paperwork following GDP/GMP guidelines.

  • Receive and distribute supplies into the production area as necessary.

  • May perform other duties as assigned.

Education & Experience Requirements

Requires high school diploma with 0-2 years’ work experience.

Key Skills and Competencies

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

  • Knowledge of cGMP manufacturing and SOP’s.

  • Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

  • Results oriented and possess the ability to work independently as well as within a team environment.

  • Must have the ability to correctly complete high school-level mathematics.

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

  • Must be able to read, write, and converse in English.

  • Must be able to navigate, conduct searches, and fill on-line forms on Personal Computer for the purposes of training, performance management, and self-service applications.

  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.

  • Must be self-motivated.

  • Must have basic level computer skills.

  • Knowledge of basic chemical and biological safety procedures.

  • The incumbent must work in a controlled environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

  • Basic Knowledge of Cell Culture, Purification, and Formulation/Filling operations and capabilities.

  • Understands Manufacturing Production Process as it pertains to: Visual product integrity processes; Visual inspection of components, finished goods and imprinting; Manual and semi-automated packaging; Product labeling

  • Understands Manufacturing Production Flows for all product lines.

  • Understands the flow and design/interdependency of manufacturing support departments

  • Knowledge of clean room management.

  • Basic knowledge of microbiology.

  • Knowledge of inventory management.

  • Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting

  • 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 apply quantitative analysis to analyze process performance.

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

  • Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:

Leadership Behaviors

  • Be Positive

  • Be Accountable

  • Be Results Oriented

  • Be An Excellent Manager of Self and Others

Working Environment

  • This position requires shift, weekend and holiday work.

  • Must be able to work in controlled unclassified environment 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 these work environments.

  • Inside working conditions.

  • Overtime may be required at times.

  • May be required to work or be assigned to a different shift as needed.

  • Must be able to work more than 8 hours a day or 40 hours a workweek as required.

  • Will have interaction with other people.

  • Pace may be fast and job completion demands may be high.

  • Position requires usage of computer.

Physical Demand

The overall physical exertion of this position requires medium to heavy work.

  • May be required to sit between 1-2 hours in all Manufacturing areas.

  • May be required to walk between 3-4 hours in Bulk and over 4 hours in the Suite A areas.

  • May be required to stand for 3-4 hours in Bulk and Suite A.

  • May be required to bend at the neck/waist for up to 1 hour in Bulk, between 1-2 hours in Suite A.

  • May be required to squat up to 1 hour in Bulk, and between 1-2 hours in Suite A.

  • May be required to climb (use step stools and ladders) up to 1 hour in all Manufacturing areas.

  • May be required to reach above/below the shoulder between 1-2 hours in Bulk and Suite A.

  • May be required to kneel up to 1 hour in all Manufacturing areas.

  • May be required to twist at the neck up to 1 hour in Bulk and Suite A.

  • May be required to twist at the waist up to 1 hour in Bulk and between 3-4 hours in the Suite A areas.

  • May be required to lift up to 75lbs in Bulk and over 75lbs in the Suite A area. Lifts per shift are up to 14 times in Bulk and Suite A.

  • May be required to carry up to 25lbs in Bulk and Suite A. Carry distance of up to 30ft in Bulk and Suite A. Carries per shift are up to 6 times in Bulk and up to 14 times in Suite A.

  • Requires repetitive use of both right and left hands and arms up to 3-4 hours in all Manufacturing areas.

  • May require simple grasping up to 1 hour in Bulk and Suite A.

  • May require power grasping up to 1 hour in Bulk and Suite A.

  • May require fine manipulation up to 1 hour Bulk and Suite A.

  • May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Suite A.

  • May require office work activities with hands/arms up to 1 hour in Bulk and between 1-2 hours in Suite A.

  • May be required to gown frequently and balance when gowning into clean areas.

  • Will not be required to drive cars, trucks, forklifts or other equipment.

  • May be required to work around moving equipment and machinery.

  • Will not be required to walk on uneven ground.

  • May be exposed to noise above 85 dBA in Bulk and Suite A. This may require hearing protection and other protective equipment to be worn.

  • May work and have exposure to hot, cold, wet environment/conditions in all Manufacturing areas.

  • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.

  • May be required to work at heights above floor level.

  • Will not be required to operate foot controls or repetitive foot movement.

  • May require the use of special visual or auditory protective equipment in Bulk.

  • May be required to drive to travel to other facilities, training sites, and off site meetings.

  • May be required to work in confined areas.

Will require entering a 2-8 degree Celsius & -60 degree Celsius freezer to store and retrieve materials and various chemicals in support of Mfg. such as IPA, 500ppm sodium hypochlorite in the F/F area.

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.