The Woodlands, Texas

Sr. Quality Engineer   (The Woodlands, Texas) 
Do you want to be part of a team that is working to change patients' lives and making a real impact to their families? Our client’s mission is to accelerate the development of innovative discoveries into life-changing biological products, and to expand global access to medicines to patients in need. 

Award-winning biopharmaceutical contract services organization is currently hiring a Sr. Quality Engineer to support all QA activities related to Facility Engineering,  and Validation in a Contract Manufacturing and Development Organization (CDMO).  This position is a Direct Hire. 

The Quality Engineer will be responsible for identifying potential problems with respect to compliance, production or testing activities and working with the affected departments to resolve the issues, and provide  oversight for facility, utility, equipment, IT, and process change controls, deviations, CAPA and Technical Documents, as well as supports client and regulatory audits.

Responsibilities:
Build upon a foundation of world-class analytical capabilities to ensure delivery of efficient processes for clinical and commercial cGMP manufacturing services (services for mammalian, microbial, and cell therapy programs). 
Assure that processes, facilities, documentation and systems conform to quality standards and governmental regulations.  
Review and approval of GMP documentation, resulting in timely QA oversight of equipment, utilities, IT infrastructure & enterprise systems and processes qualification/validation activities.
Provide input and compliance review on the following records: Qualification/validation plans, protocols, & reports, Change Controls, and deviations and CAPAs related to facility, utility, equipment and processes. 
Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
Interface directly with clients, provides updates and resolves issues.
Review the following equipment-related documentation: user requirements specifications, qualification plans, protocols, and final reports, SOPs, work plan & calibration templates, and out of calibration reports.
Train and mentors other Quality department staff to perform quality duties.
Participate in client project teams.
Supports client and regulatory audits.

Qualifications:
B.S. Degree and 12+ years’  experience,  or M.S. Degree  and 10+ years’ experience in a QA or GMP environment, or equivalent  desired.
Over 5 years of validation experience, 15+ years in pharma/biotech with 10 of those years in Quality.
Inter- and intra-departmental project management experience and experience with electronic document management systems desired.
Strong track record in quality assurance, validation, cGMP and engineering experience in the pharmaceutical and biotechnology fields.
Capable of providing strong technical guidance and assistance on current industry standards for validation and quality related issues (Validation, CAPA, Auditing, Complaints, Exceptions, and OOS, etc.). 
Validation experience to include auditing, responding to complaints, continued process verification, computer systems,  sterilization, cleaning, aseptic processing and product and technology transfers and scale-up a plus. 
Demonstrated successful track record in development and implementation of international compliance strategies.
Biologic and/or cell therapy experience, in addition to someone at the Principal level that is an SME in lab instruments, IT system validation and data integrity experience.

Client provides fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally, and offers a challenging, rewarding and fast-paced environment, along with the opportunity for career advancement through the development of one’s technical skills. 



Why Kelly®?

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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The Woodlands, Texas

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