12 days old

Manufacturing Tech IV

Baxalta U.S., Inc.
Thousand Oaks, CA 91362
  • Job Code
    R0038425

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manufacturing Tech IV in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

The Manufacturing Technician IV 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 IV is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the Manufacturing Lead and the overall direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. In addition to making routine revisions to documents, this position may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. The position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills. All the specific requirements presented in this job description are applicable to the functional area in which it resides.

Essential Duties and Responsibilities

  • Visual inspection of lyophilized product vials, empty vials for glass defects, washout defects and rubber stoppers for defects.
  • Conduct visual inspection of needles and assemble needle packs.
  • Load/unload materials to conveyors and packaging carousel.
  • Operate pallet jack and shrink wrap
  • Receive and distribute supplies into the production area as necessary.
  • Initiate or coordinate continuous improvement and departmental projects.
  • Conduct documentation review and update/revise SOPs (Standard Operating Procedures)
  • Rewrite complex procedures or initiate new procedures as applicable.
  • Initiate work requests, conduct inventory handling & CGMP inspections/audits
  • Diagnosis equipment problems and implement corrective actions.
  • Provide critical process monitoring, perform complex trouble shooting tasks and assist during the transfer of new technologies into manufacturing.
  • Serve as the main interface with other departments to resolve issues related to equipment, process and compliance.
  • Train and mentor junior level technicians.
  • Assist the lead & supervisor in organizing, scheduling and directing team members.
  • Perform safety and CGMP inspections or observations.
  • Ensure timely and accurate generation of process documentation.
  • May perform other duties as assigned.

Qualifications

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Knowledge of cGMP manufacturing and SOPs.
  • 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 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.
  • The incumbent must work in a controlled environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
  • 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.
  • 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.

Education and/or experience

  • High school diploma or equivalent required.
  • 3 4 years of related work experience preferred.
  • Or AA degree with 2-3 years of related manufacturing experience.

Physical Demands

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

  • May require the use of special visual or auditory protective equipment.
  • May be required to work at heights above floor level.
  • Will not be required to operate foot controls or repetitive foot movement.
  • May be required to sit between 1-2 hours.
  • May be required to climb (use step stools and ladders) or kneel up to 1 hour.
  • Requires repetitive use of both right and left hands and arms up to 3-4 hours.
  • May be required to sit over 4 hours; walk between 1- 2 hours; stand between 3-4 hours.
  • May be required to bend at the neck between 3-4.
  • May be required to bend at the waist for under 1 hour.
  • May be required to squat between 1-2 hours.
  • May be required to reach above/below the shoulder and twist at the neck/waist up to 1 hour
  • May be required to lift up to 50 lbs, carry up to 25 lbs (carry distance up to 20 ft); carries & lifts per shift vary between 2 times, up to 100 times.
  • Requires repetitive use of both right and left hands and arms for over 4 hours.
  • May require simple grasping & fine manipulation for over 4 hours; power grasping for up to 1 hour.
  • May require pushing/pulling with hands/arms between 1-2 hours.
  • May require office work activities with hands, arms for over 4 hours.

Working Environment

  • Must be able to work in controlled or clean room 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 these work environments.
  • May be 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.
  • May work and have exposure to hot, cold, wet environment/conditions
  • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
  • May be required to work in confined areas; may be required to work around moving equipment and machinery
  • May be required to drive to travel to other facilities, trainingsites, and off-site meetings.
  • Will not be required to walk on uneven ground.
  • May require office work activities between 1-2 hours.
  • May require overtime, weekend and holiday work.
  • May be required to work or be assigned to a different shift as needed.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

This posting excludes CO applicants.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
ADP Logo
Sponsored by:
Bank of America Logo

Featured Jobs[ View All ]

Featured Employers

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manufacturing Tech IV

Baxalta U.S., Inc.
Thousand Oaks, CA 91362

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast