cGMP Computer Systems Associate

cGMP Computer Systems Associate

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 Computer Systems Associate who will aid in the implementation, and maintenance of electronic systems related to QC, QA, and manufacturing in a cCMP environment.

Primary Responsibilities:

• Participate in implementation of electronic systems such as LIMS and QMS.
• Works to ensure the quality electronic systems are audit ready and follow the applicable guidelines (SOX, GMP, GXP).
• Maintain the computer system validation of the electronic systems and any QC equipment software.
• Execution of computer system qualification documents.
• Comply with data integrity standards and Data management.
• Interact with the Quality Control, Quality Assurance and Manufacturing teams as needed to provide user support in a timely manner.
• Understands and participates in corrective or preventative actions and be able to improve systems and procedures as applicable.
• Other duties as assigned.

Requirements and Preferred Qualifications:

• Bachelor's Degree in Information Technology or Life Sciences.
• Experience in a biotech or pharmaceutical setting is preferred.
• Knowledge of LIMS and QMS.
• Background that includes knowledge/experience of GMP, GLP, GCP, USP, and/or ICH requirements, CVS and Software IQ/OQ/PQ.
• Ability to take a proactive approach on the job with the ability to work with a dynamic team.
• Excellent writing and editing as well as written/oral communication skills are required.
• Ability to work in a fast-paced changing environment in conjunction with the quality team and know how to prioritize activities appropriately.
• Must be detail oriented and conscientious. Ability to understand and follow written procedures.
• Excellent oral and written communication skills.

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.