In this newly created role, the Specialist, Mechanical Maintenance – Gene Therapy monitors the manufacturing and laboratory equipment. This includes performing activities required to support the Preventative Maintenance and Corrective Maintenance program in accordance with Good Manufacturing Procedures (GMP) regulations and company Standard Operating Procedures (SOPs). This includes ensuring that these activities are properly documented. Instrument services may be performed in GMP, Good Lab Practices (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 Specialist, Mechanical Maintenance – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Performs daily monitoring, preventative maintenance, and repairs of 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.
Participates in the continuous improvement efforts within the site Maintenance Program.
Provides support for start-up, commissioning, and turnover of new systems.
Performs preventative and predictive maintenance on related clean utilities and systems that support Process Manufacturing.
Maintains water rooms and related equipment. This includes, but may not be limited to, pumps, motors, WFI stills, Clean Steam Generators and related piping.
Troubleshoots and repairs all related clean utility equipment and systems and Water for Injection (WFI) point of use flushing.
Maintains documents and records on all validated equipment and systems.
Interfaces with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems.
Maintains up to date training records.
Communicates with management regarding change documentation, as necessary.
Follows current Good Manufacturing Practices (cGMPs).
Communicates and coordinates with each department and within Facilities Management when planned and unplanned work events occur.
Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
A High School diploma and a minimum of 4 years of facilities maintenance/operations experience in a pharmaceutical, biotechnology or related environment OR the equivalent combination of education and experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Knowledge of Preventive Maintenance and calibration disciplines within a cGMP Biotechnology, Pharmaceutical or related manufacturing environment.
Knowledge of cGMP, GXP, Good Automated Manufacturing Practice (GAMP), Software Development Life Cycle (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.
A minimum 4 years of GMP facility experience.
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.