Job Description
Calibration/Maintenance Technician About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end to end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary: Krystal Biotech, Inc is seeking a highly motivated Calibration & Maintenance Technician who will be responsible for the calibration and maintenance of all systems, devices and items requiring calibration at Krystal Biotech. The Technician will play a key role in the day-to-day support of the calibration, metrology, and maintenance program.
Primary Responsibilities: - Responsible for performance of routine calibration and maintenance
- Operate the metrology program in adherence with site Standard Operating Procedures (SOPs)
- Coordinate external services to ensure qualified resources are supporting the calibration efforts
- Align calibration schedules with internal departments to ensure staff and equipment availability
- Review all paperwork to ensure calibrations are documented according to the site’s guidelines and SOPs
- Promptly report any and all out of tolerance (OOT) findings in alignment with approved SOPs
- Investigate, document and report all calibration issues in alignment with the sites Corrective Action, Preventive Action (CAPA) program
- Provide support as SME for the site’s building monitoring and alarm systems
- Assist in the paperwork and data entry of new items needing calibration support
Experience and Skills Desired: - High School Diploma
- Relevant educational training in Associate or Trade School programs preferred
- Mechanical aptitude with strong troubleshooting skills and demonstrated knowledge of proper usage of power equipment, hand tools, and measurement equipment
- Experience in an industrial or pharmaceutical maintenance/metrology setting preferred
- Familiar with Metrology practices in a cGMP environment preferred
- Must be hands-on and a self-starter
- The following competencies are highly preferred, but not required:
- Knowledge of metrology software systems and related equipment in a pharmaceutical setting
- Prior experience with methods to verify/confirm equipment tolerances
- Previous testing of biosafety cabinets, fume hoods and air balance programs
- Knowledge of EH&S and OSHA practices
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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Job Tags
Full time,