Shire Manufacuting Technician II in Thousand Oaks, California

Essential Functions

Responsibilities

  • Perform environmental and utility monitoring at the Shire manufacturing facilities.

  • Use of laboratory instrumentation including but not limited to: analytical equipment, autoclaves, Climet, and SAS air samplers.

  • Will use computer systems (LIMS) to collect and record data.

  • Perform test equipment, equipment maintenance and calibrations as required.

  • Perform review of test data, which includes overall documentation practices (cGDP). Perform release functions in LIMS or other computerized systems.

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

  • Visual inspection of lyophilized product vials, Visual inspection of empty vials for glass defects, Visual inspection of empty vials for washout defects, visual inspection of rubber stoppers for defects

  • 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.

  • Operate pallet jack and shrink wrap

  • Manually clean equipment and conveyors.

  • Load/Unload materials to conveyors and packaging carousel.

  • Responsible for Biodecontamination 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

  • Intermediate 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.

  • Ability to train and qualify others if qualified.

  • May perform other departmental tasks as required

  • May perform other duties as assigned.

Education & Experience Requirements

Requires high school diploma with 1-3 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 intermediate level computer skills.

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

  • 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.

  • 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

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

  • Passion for Improving Lives. Must be able to put our patients at the center of everything we do.

  • Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.

  • Inspired Teams environment. Must be able to thrive in diverse high performing teams.

  • Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.

Other Job Components

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 Bulk and F/F, for up to 1 hour in Suite A and over 4 hours in the Packaging area.

  • May be required to walk between 3-4 hours in Bulk, over 4 hours in Suite A and F/F and between 1-2 hours in the Packaging area.

  • May be required to stand between 3-4 hours in Bulk, for over 4 hours in Suite A, F/F, and Packaging.

  • May be required to bend at the neck for up to 1 hour in Bulk, for over 4 hours in Suite A and F/F and between 3-4 hours in the Packaging area.

  • May be required to bend at the waist for up to 1 hour in Bulk, between 1-2 hours in Suite A, over 4 hours in F/F and under 1 hour in the Packaging area.

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

  • 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, up to 1 hour in Suite A and Packaging and between 3-4 hours in F/F.

  • May be required to kneel up to 1 hour in Bulk and F/F, between 1-2 hours in Suite A and up to 1 hour in the Packaging area.

  • May be required to twist at the neck/waist up to 1 hour in Bulk and Packaging, between 3-4 in F/F, and over 4 hours it the F/F area.

  • May be required to lift up to 75lbs in Bulk and up to 50lbs in the Suite A, F/F and Packaging areas. Lifts per shift vary between 2 times, up to 100 times in all Manufacturing areas.

  • May be required to carry up to 25lbs in Bulk, F/F and Packaging and up to 50lbs in Suite A. Carry distance of up to 20ft in all Manufacturing areas. Carries per shift vary between 2 times, up to 100 times in all Manufacturing areas.

  • Requires repetitive use of both right and left hands and arms between 3-4 hours in Bulk and F/F and for over 4 hours in Suite A and Packaging.

  • May require simple grasping for up to 1 hour in Bulk, between 3-4 hours in F/F and over 4 hours in Suite A and Packaging.

  • May require power grasping for over 4 hours in Suite A and F/F and up to 1 hour in the Packaging and Bulk areas.

  • May require fine manipulation for over 4 hours in Suite A and Packaging, up to 1 hour in Bulk and between 1-2 hours in F/F.

  • May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Packaging, between 3-4 in F/F and over 4 hours in Suite A.

  • May require office work activities with hands/arms up to 1 hour in Bulk and Suite A, between 1-2 in F/F and over 4 hours in the Packaging area.

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

  • May be required to drive a car, truck, forklift and other equipment in the Packaging area

  • May be required to work around moving equipment and machinery in all Manufacturing areas.

  • Does not require walking on uneven ground.

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

  • May work and have exposure to hot, cold, wet environment/conditions in Suite A, Bulk and F/F.

  • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes in Suite A, Bulk and F/F. May require respiratory protection.

  • May be required to work at heights above floor level in Suite A, Bulk and F/F.

  • Does not require operation of foot controls or repetitive foot movement.

  • Does require the use of special visual or auditory protective equipment in Bulk and F/F.

  • Does require working with biohazards such as: bloodborne pathogens, sewage or medical waste in F/F.

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

  • May be required to work in confined areas.

  • Requires 20/20 vision corrected with near vision acuity in the Packaging area.

  • 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 F/F area.

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.