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Environmental Monitoring Supervisor

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Job ID R0043895 Date posted Aug. 19, 2021 Location Thousand Oaks, California

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Job Description

The EM Supervisor is 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.

Qualifications

  • Demonstrated supervisory and leadership skills.
  • Demonstrated continuous improvement proficiency in lean / six sigma.
  • Able to manage multiple priorities in manufacturing plant setting.
  • Understands Manufacturing Production Process for all functional areas.
  • 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
  • Knowledge of basic chemical and biological safety procedures.
  • Proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
  • Strong interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Able to operate with agility and a learning mindset.

Education and/or experience

  • Bachelor’s Degree in Microbiology or Biological Sciences strongly preferred.
  • Minimum 3 years of related work experience.
  • Minimum 2 years of leadership experience preferred.
  • Lean leadership experience preferred.
  • Experience in laboratory, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.

Working Environment

  • Office work environment
  • May work in controlled or clean room environments requiring special gowning.
  • This job posting excludes CO applicants.

EEO Verbiage for US Reqs

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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