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About Clinigen and the Role:
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
About Clinigen and the Role:
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
The Metrology Technician supports the day-to-day management of metrology, EMS and the validation and qualification of facility equipment throughout the site. Additionally, maintains the qualified condition of storage environments, production environments, and equipment associated with different environments.
Requirements
The successful candidate will have:
- High School Diploma or Equivalent
- 1-3 years' experience in metrology, validation, qualification
- Experience in GMP, GLP, GDP, and GxP
- General knowledge of technical buildings
- Experience in the pharmaceutical or Bio-Tech industries
- Knowledge of ventilation and cleanroom filtration standards
- Knowledge of electricity, electronics, and mechanical calibration techniques
- Excellent analytical and problem-solving skills
Your role at Clinigen:
- Apply knowledge of measurement science, mathematics, physics and electronics to calibrate measurement equipment in electrical, dimensional, optical, physical, mechanical, environmental and/or chemical to ensure accurate measurements
- Define a maintenance, calibration and monitoring schedule for production equipment/facilities
- Define a schedule for the maintenance and monitoring of the environmental survival system
- Ensure the recurrent performance qualification (mapping) of all cold rooms, freezer rooms, ambient rooms and freezers
- Calibrate and adjust temperature, pressure, or humidity sensors taking corrective action as necessary
- Review and approve calibration certificates and validation documents
- Perform the cleaning and storage of calibration equipment and/or the department
- Perform installation/operational/performance qualifications of cold rooms, freezer rooms, ambient rooms and freezers
- Participation in the on-call rotation for facility monitoring
- Ensure that preventive and corrective maintenance is performed in a timely manner to avoid deviations and/or breakdowns, in accordance with production planning, environmental specifications, and appropriate GxP standards
- Provide support to operational departments in terms of qualification and validation both annually and for new systems, equipment or infrastructure in accordance with our quality standards and GxP regulations
- Collaborate with the Quality and Operations departments to ensure compliance / write the SOPs, WIs, and all other documents necessary to perform the annual monitoring of the equipment/systems and facilities in its areas of responsibility
- Follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
We're excited about you if you have:
- Experience in metrology or validations
- Experience in Pharmaceutical and or Bio-Tech industries
Benefits
While at Clinigen, you'll enjoy:
The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague's Clinigen experience can be a bit different, and we're proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We've been able to take steps to continuously improve how we do things at Clinigen.
The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.
EEO. Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.
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