Quality Assurance Validation Engineer
Quality Assurance Validation Engineer
About Krystal Bio:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.
Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.
We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated individual to lead Quality Assurance support of validation activities.
Specific responsibilities include but are not limited to:
- Represent Quality Assurance from the validation perspective for projects, and report quality issues and trends
- Coordinate and execute validation master plans; review and create qualification and/or validation reports
- Provide Quality oversight of commissioning, qualification and validation programs, which include review and approval of records and documents generated by supported groups
- Provide Quality support for facility and manufacturing related qualification documents (DQ/IQ/OQ/PQ, Calibration, Validation, etc.)
- Provide QA review of facility, supply chain, QA, and manufacturing SOPs, protocols, risk assessments, reports, raw data and hold time studies
- Partner with equipment, maintenance and facilities team members on requirements for equipment qualification and calibrations
- Perform QA review of Computer Systems Validation (CSV) documents, including risk assessment, validation plan, IQ/OQ/PQ, and validation summary reports
- Provide QA review of Process Validation (PV) activities, including risk assessments and data analysis
- Provide QA support of site cGXP documentation related to the operation of gene therapy manufacturing facility/laboratory to ensure compliance with regulatory agencies and oversee continuous improvement of company's quality assurance and compliance functions
- Work with SMEs to evaluate new and existing regulations, changes to existing regulations, and regulatory trends, and to perform gap analyses to determine deficiencies and recommend appropriate action
- Ensure company guidance documents are up to date and compliant
- Provide QA subject matter expert (SME) support for business activities
- Assist in impact assessments with process owners for proposed changes to processes, systems, equipment, etc. and work to identify required actions to remedy impacts of changes (e.g. re-validation, verification, etc.)
- Participate in review and support of investigations related to discrepancies and deviations, as well as related CAPAs related to qualification and validation; provide support for root cause analysis, devising action plans and determination of effectiveness of corrective actions.
- Participate in internal audits and external inspections/audits (e.g. FDA inspections) as QA support and QA-validation SME
- Analyze data from validation group for annual product review and provide validation status reports for Quality Management Review activities
- Other duties as assigned
Experience and Skills Desired:
- Minimum of a Bachelor’s Degree (Biology or related Life Science; background in Engineering preferred) with 1+ years of relevant quality and/or validation experience in the Biotech or pharmaceutical industry
- Background that includes knowledge/experience of GMP, GLP, GCP, USP, and/or ICH requirements
- Prior experience in the gene therapy field is desired
- Must be a self-starter and capable of working with minimal oversight
- Excellent writing and editing as well as written/oral communication skills are required
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. 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