Contract, Calibration Technician - CMC Labs
Employment Type: Full-Time
Job Description Summary:
The Contract, Calibration Technician - CMC labs is responsible for equipment calibration operations that comply with ISO17025 and ANSI Z540 metrology standards and Good Manufacturing Practices (GMP) regulations. This includes ensuring that these activities are properly documented. Instrument services may be performed in GMP, GLP, Non-GMP process and laboratory areas.
The incumbent works cross-functionally with internal departments and external resources as appropriate on maintenance and repair-related issues.
The GMP Calibration Technician ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
* Calibrates and repairs manufacturing and laboratory equipment in accordance with SOPs, ensures proper documentation practices are followed and ensures that there is minimal or no interruption in the daily manufacturing schedules.
* Maintains and performs corrective and preventative maintenance calibrations on GMP and non-GMP equipment.
* Supports other departments to troubleshoot, test, repair and optimize instruments, equipment, and control systems.
* Oversees the maintenance and review of calibration standards and vendor calibration documentation.
* Provides leadership for start-up, commissioning, and turnover of new systems.
* Provides direct oversite of technicians and external vendors to ensure compliance.
* Completes and reviews documentation associated with calibration work orders to ensure cGMP good documentation practices and change control procedures are being followed.
* Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
* An Associates degree in Engineering or Technical certification in instrumentation and a minimum of 3 years of equipment calibration experience in a pharmaceutical, biotechnology or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
* 2-5 years of GMP facility experience.
* Advanced knowledge of calibration disciplines within a cGMP Biotechnology / Pharmaceutical manufacturing environment.
* Knowledge of cGMP, GXP, GAMP, SDLC regulations, Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
* Proficiency with Computerized Maintenance Management Systems (CMMS).
* Excellent verbal and written communication and skills.
* Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
* Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
* Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
* Travel requirements
* Physical requirements
* Lab and Manufacturing based position
At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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