Aseptic Processing Expert
Apply locations US - Houston, TX time type Full time posted on Posted 30+ Days Ago job requisition id R62657
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have an exciting opportunity in our Viral Vector Manufacturing group. The role of the Manufacturing Suite Point of Contact (POC) is to act as an aseptic champion driving cleanroom management, on the floor observations and leading aseptic improvement projects for manufacturing operations. On a daily basis the POC will be responsible for fulfillment of immediate requests from the MFG support departments including, but not limited to, work order initiation for calibration and facilities/suite maintenance, Out of Service (OOS) tag placement and removal. Outside of daily requests, the POC will own the suite specific planning schedule, POC walk throughs performed on a regular basis, maintain graded and production areas audit ready!
To further support the daily operation of the suite, the POC will assist MFG technicians by providing guidance on aseptic behaviors on the production floor. The POC will initiate/work/close change controls, CAPAs and support with minor track and trend deviations.
Key responsibilities:
- Champion holistic approaches to sterility assurance through a combination of robust aseptic practices and continuous improvement. Lead by example to embed a strong quality and sterility assurance culture within manufacturing teams and across support functions.
- Drive and maintain good cleanroom management practices.
- Ensure substantial ‘on the floor’ presence, providing real-time education, feedback and coaching to manufacturing teams that establishes, improves and maintains good aseptic behaviors and cleanroom standards.
- Work cross-functionally with scheduling to identify and plan for any non-routine suite and equipment windows needed (Calibration/Maintenance).
- Coordinate placement and removal of quality tag-outs.
- Own and manage change controls, CAPA’s and support with minor track and trend deviations.
- Create, update and own changes on standard operating procedures used by CT manufacturing.
- Administrative tasks – attending shift exchange and daily production meetings, sending/receiving emails, training, etc.
Key requirements:
- Bachelor’s Degree in Biotechnology, Biology, Chemistry, or equivalent with Associates degree.
- High School Diploma or Equivalent may be considered with relevant experience.
- Significant experience of pharmaceutical aseptic production for drug product manufacture/compounding.
- Strong understanding of regulations and good manufacturing practices relevant to aseptic manufacture of sterile drug products.
- Possess solid critical thinking and problem solving skills.
- Able to use experience and knowledge to propose solutions (conventional and non-conventional).
- Strong decision making skills.
- Able to assess options, pros/cons, risks to product/safety/quality/business and aide in prompt decision making under dynamic conditions.
- Effective communicator, verbal and written.
- Flexible, able to respond to daily changing demands.
- Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels.
- Strong planning and organizational skills.
- Able to manage a fluid daily schedule.
- Able to have a holistic view of suite planning, at least a month out, and recognize potential impact and needs as a result of changing demands.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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