MSAT/Continuous Improvement Specialist
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 has an exciting new role for an MSAT / Continuous Improvement Specialist in Kingston, ON. This role plays a crucial role in Personalized Medicine (PerMed) by leading and executing, a) Technical Transfers, b) complex technical investigations, c) process continuous improvements (D2E-Lonza CI Program).
- Ensures that new products are introduced in our cGMP facility meeting Regulatory/Business expectations
- Performs process gap analysis using risk analysis tools such as pFMEA and authoring gap analysis reports
- Leads New Product Introduction Change Control and authors Process Description Reports and supports process qualification validation activities as needed
- Leads the receiving team workstream and is accountable for tech transfer milestones to commercial
- While supporting complex technical investigations, uses root cause analysis tools such as Causal Branching, Fault Tree Analysis, Event and Causal Factor Charting and Defense Analysis
- Authors technical reports and use Quality Systems tools such as TrackWise/Smartsheet and Document Management Systems (DMS) to document investigations and technical studies.
- Manages related Change Controls/Deviations/CAPAs following Lonza’s SOPs and Quality Systems tools and acts as SME during internal and External audits
- While continuous monitoring of GMP processes, uses statistical analysis to identify opportunities for improvement such as reduce process variability, streamlined manufacturing processes, increase efficiency
- Drives the implementation of the elaborated improvements on commercial scale to raise profitability and to achieve sustainable business success while fostering good customer relationship with stakeholders
- Accountable for project results by planning, monitoring and managing projects/lab programs from initiation through completion
- Collects, summarizes, analyzes data to prepare reports and makes presentations, as appropriate, to disseminate best practice throughout the function
- Supports DOE/FATs/SATs activities including IQ/OQ/PQ of new equipment by providing process knowledge expertise to the team.
On floor support:
- Provision of technical assistance to Manufacturing for critical operations that require specific knowledge going beyond routine manufacturing operations (e.g. new processes, new procedures).
- Maintains Device History File, Device Master Record and technical transfer documentation to support Drug Master File, Technical files, conformity assessment files, and country specific files.
- Technical contact for development of projects with R&D and PD
- Bachelor’s degree in an Engineering or Scientific discipline; P.Eng a plus.
- Project Management Certification (PMI) and/or Quality Certification (ASQ) a plus
- Significant experience in Process Controls/Validation/Design Transfer in Medical Device (ISO13485.2016)
- Thorough knowledge of cGMP/GLP/ISO 13485/US FDA 21 CFR 820/EU Directives/ICH9/ICH 10/ATMP
- Significant Lean Six Sigma experience (Black Belt a plus)
- Able to translate opportunities into workable solutions
- Strong analytical and problem solving skills coupled with the ability to work both independently and in a team environment
- High attention to detail
- Strong computer skills and proficiency in written and verbal communication
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.