Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
Every vial has a name is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise. We have an excellent opportunity for a high performing Manufacturing Supervisor, Environmental Monitoring.
The selected candidate will be responsible for implementing and supervising the Environmental Monitoring and Utilities Monitoring Program for all manufacturing areas to ensure goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. Focus is on ensuring product quality while adhering to compendial and facility requirements.
Essential Duties and Responsibilities
- Supervise the day to day production, scheduling, staffing, material management, compliance, training, and auditing activities related to Environmental Monitoring.
- Lead the department continuous improvement initiatives via Takeda s agile operating system.
- Develop and manage performance of direct reports.
- Provide training to new and existing employees and ensures training compliance metrics are met.
- Enforce regulatory compliance.
- Perform investigations into EM related excursions and adverse trends.
- Work with Metrology to ensure equipment calibration schedule is maintained and in compliance.
- Support and ensure the execution of all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Lead technical reviews, investigation and process improvement projects.
- Provide input into integration and validation of new equipment and process.
- Resolve technical, material, and cGMP issues.
- Review, approve, and manage documentation for batch and system records for production.
- Interface with other departments to help resolve issues related to equipment, process and compliance including facility support departments and external vendors.
- Lead in technical reviews, investigation and process improvement projects in order to meet objectives
- Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, assist with training and auditing as appropriate.
- Owner for implementation of new equipment, system and/or procedures.
- Participate in Internal or external audits as SME for department.
- May perform other duties as assigned.
- Demonstrated supervisory and leadership skills.
- Demonstrated continuous improvement proficiency in lean / six sigma.
- Able to manage multiple priorities in manufacturing plant setting.
- 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.
- Understands Manufacturing Production Process for all functional areas. Expertise grows in depth and breadth as individual moves up the career ladder.
- Knowledge of Utility Systems and how they impact the Manufacturing Departments.
- Understands the flow and design/interdependency of manufacturing support departments.
- Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting.
- Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
- May have more specific skill sets in areas depending on need/ opportunity: Aseptic technique.
- Knowledge of clean room management.
- Strong professional writing skills and ability to prepare and write technical reports
- Strong verbal and written communication skills across multiple functional areas.
- Computer skills, including PowerPoint, Word, Excel, Access.
- Knowledge of basic chemical and biological safety procedures.
- 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 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.
- Advanced word processing skills.
- Advanced spreadsheet skills.
- Advanced typing skills.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- 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.
- May support cross functional teams
- Conduct documentation review, as needed
- Communicate to supervisor any concerns and feedback related to floor issues
- Support LDI-phase I-GEMBA to address housekeeping concerns
- Serve as area department contact and back-up when manager is not present or as needed. As the manager back-up, supervisor will be expected to support trouble shooting activities, contact support groups when external assistance is required and make decisions within experience and comfort level, elevating.
- Employee 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.
Education and/or experience
Bachelor s Degree preferred plus 3-6 years of manufacturing experience, or AA Degree with 5-7 years of manufacturing experience, or HS Diploma with 7-10 years of manufacturing experience.Minimum of 2-4 years of leadership experience.Scientific or engineering degree preferred.Lean leadership experience preferred.
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 F/F and Suite A areas.
- May be required to stand for 3-4 hours in Bulk and Suite A and over 4 hours in F/F.
- May be required to bend at the neck/waist for up to 1 hour in Bulk, between 1-2 hours in Suite A and over 4 hours in the F/F areas.
- May be required to squat up to 1 hour in Bulk, and between 1-2 hours in Suite A and 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 and Suite A and between 3-4 hours in the F/F areas.
- 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 and between 3-4 hours in the F/F area.
- May be required to twist at the waist up to 1 hour in Bulk and between 3-4 hours in the F/F and Suite A areas.
- May be required to lift up to 50lbs in the F/F area, 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 and up to 100 times in the F/F area.
- May be required to carry up to 25lbs in Bulk and Suite A and up to 50lbs in the F/F areas. Carry distance of up to 30ft in Bulk and Suite A and up to 6 feet in the F/F areas. Carries per shift are up to 6 times in Bulk, up to 14 times in Suite A and up to 100 times in the F/F areas.
- 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 and between 3-4 hours in the F/F areas.
- May require power grasping up to 1 hour in Bulk and Suite A and over 4 hours in the F/F areas.
- May require fine manipulation up to 1 hour Bulk and Suite A and between 1-2 hours in the F/F areas.
- May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Suite A and between 3-4 hours in the F/F areas.
- May require office work activities with hands/arms up to 1 hour in Bulk and between 1-2 hours in Suite A and the F/F areas.
- 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 and F/F areas.
- May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste in the F/F areas.
- 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.
- 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 work in a cold, wet environment.
- May be exposed to dust, gases, and fumes.
- May be around and operating moving equipment and machinery.
- May climb up and into large processing tanks for cleaning or inspection.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.
- May be required to work in a confined area as defined by the Environmental, Health, & Safety office.
- Possible exposure to cool/hot storage conditions.
- Will have interaction with other people.
- Pace may be fast and job completion demands may be high.
- May be required to travel for business reasons, e.g. training and meetings .
- 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.
- This position requires shift, weekend and holiday work.
- Maybe required to work 4 days a week 10 hour days.
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, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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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Shire, a wholly-owned subsidiary of Takeda, 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.