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Senior Technician, GMP Calibration - Gene Therapy at PTC Therapeutics, Inc. in Pennington, New Jersey

Posted in Manufacturing 30+ days ago.

Type: Full-Time





Job Description:

Job Description Summary:

Job Description:

PTC Therapeutics is recruiting for a Senior Technician, GMP Calibration - Gene Therapy role. This role will be based at our Hopewell, NJ location.

PTC has been successful over the years because our team is deeply committed to a single purpose: Extending life’s moments for patients with rare diseases and their loved ones. Our biggest accomplishments have always been measured by units of time – or “measured by moments.” Whether our therapies grant hours, days, months or years, every small moment is an enormous win.

The Senior Calibration Technician - Gene Therapy is responsible for equipment calibration operations that comply with ISO17025 and ANSI Z540 metrology standards and current 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 Senior Calibration Technician supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Primary duties/responsibilities:

  • Performs calibration, testing, troubleshooting and repairs on manufacturing and laboratory equipment in accordance with SOPs. Ensure 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.
  • Recommends 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.
  • Writes and reviews calibration procedures, prepares documentation, inputs data, and generates reports associated with calibration work orders to ensure current Good Manufacturing Practices (cGMP) and change control procedures are followed.
  • Coordinates and manages daily workloads without little to no direction from manager.
  • Recommends and implements process improvements.
  • 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 or High School diploma or equivalent and 5 years of technical training and experience.

* Special knowledge or skills needed and/or licenses or certificates required.


  • 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).

  • Proficiency with Microsoft Office.

  • 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. 

*Special knowledge or skills and/or licenses or certificates preferred.

  • 2-5 years of GMP facility experience.

* Travel requirements

0%

Lab and Manufacturing based position

EEO Statement:

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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