Quality Engineer - Katalyst Healthcares & Life Sciences
Fremont, CA 94536
About the Job
Responsibilities:
- Lead complex technology transfers with a focus on right-first-time execution and risk management.
- Perform as SME to identify technical areas for improvement, and supply chain improvement.
- Lead drug product Process Performance Qualification and preparation of regulatory reports.
- Support the internal and external teams to ensure manufacturing site readiness, reliability, and sustainability.
- As needed, provide SME input on complex investigations, root cause identification, product impact assessment and corrective and preventive actions implementation.
- Represent Pharmaceutical Innovative Medicine Supply Chain in interfacing with external manufacturing company.
- Manages international sample shipments, execution of shipping route verification studies per SOPs, supports investigations and CAPAs as technical expert in the Drug Product manufacturing process.
- Reviews and approves batch records, validation protocols, data, and reports.
- Demonstrated technical competency and experience with biologic drug product.
- Demonstrated experience in managing technology transfers and/or Life Cycle Management projects and investigations.
- Partnering with R&D and JSC groups to improve the fit for plant and commercialization of new products into the supply chain.
- Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.
- Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.
- Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
- Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.
- Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.
- Ability to manage complexity and change.
- Personal attitude and mindset.
- Motivated, self-starter able to work independently with demonstrated problem solving skills.
- Drives for innovation and change to ensure competitiveness.
- Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.
- Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals, or Bachelors + 8 years.
Source : Katalyst Healthcares & Life Sciences
