Specialist, Mechanical Maintenance - Gene Therapy

PTC Therapeutics Pennington , NJ 08534

Posted 2 months ago

Job Description:Summary:

Job Description:

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.

Primary duties/responsibilities:

  • 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.

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.

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.

Click here to return to the careers page

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Scientist Quality Control (Gmp Testing) Gene Therapy

PTC Therapeutics

Posted 2 months ago

VIEW JOBS 9/2/2021 12:00:00 AM 2021-12-01T00:00 Job Description Summary: Job Description: In this newly created role, the Associate Scientist , Quality Control (GMP Testing) - Gene Therapy is responsible for the execution and analysis of compendial assays such as Appearance, pH, Osmolality, Subvisible Particles, and Conductivity to support drug substance/drug product release and stability testing for the gene therapy Technical Operation organization. Testing responsibility may also include well-established bioanalytical assays such as ELISA, qPCR, SDS-PAGE, CE-SDS, BCA and UPLC-SEC. S/He is also responsible for communicating assay results to his/her supervisor. The incumbent works cross-functionally with internal departments and external resources on Quality Control and GMP testing-related issues. The Associate Scientist , Quality Control (GMP Testing) - Gene Therapy supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate. Primary duties/responsibilities: * Performs product testing in support of the in-process, drug substance/drug product release and stability testing for gene therapy manufacturing. These include, but are not limited to, compendial and bioanalytical assays. * Documents results in a cGMP compliant manner. * Maintains detailed, up to date, and witnessed laboratory notebooks. * Performs timely peer review of analytical results. * Provides support for checking expiration dates of chemicals in lab. * Contributes to departmental activities such as safety inspections and housekeeping. * Contributes to ensuring all samples contained within QC refrigerators, freezers and incubators are clearly labeled, segregated and arranged in an orderly fashion. * Operates the instruments and interprets analytical data using Empower, Agilent, 32 Karat, SoftMax Pro, etc. * Provides support for the arrangement and organization of test folders for samples on test. * Contributes to discarding samples after testing is deemed completed. * Prepares buffers and laboratory solutions as described by relevant test methods. * Contributes to ordering reagents required for testing. * Minimum level of education and years of relevant work experience. * A Bachelor's degree in biology, molecular biology, virology, biochemistry or related discipline and a minimum of 5 years of relevant assay experience in a pharmaceutical, biotechnology or related environment or a Master's degree in these same disciplines and a minimum of 1 year of relevant assay experience in these same environments. * Special knowledge or skills needed and/or licenses or certificates required. * Knowledgeable of USP, Ph. Eur. requirements for compendial testing and experience with method execution. * Experience with using an analytical balance. * Knowledgeable of bioanalytical assays and experience with the method execution. * Experience with working in a cGMP laboratory. * Proficiency with Microsoft Office (Word and Excel). * 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. * Ability to work occasional weekends as required * Special knowledge or skills and/or licenses or certificates preferred. * Small company and/or start-up experience. * Experience with Minitab or JMP statistical desirable 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. 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. Click here to return to the careers page PTC Therapeutics Pennington NJ

Specialist, Mechanical Maintenance - Gene Therapy

PTC Therapeutics