Job Description

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there\xe2\x80\x99s 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\xe2\x80\x99s the kind of work we want to be part of.

Lonza Kingston is IMMEDIATELY hiring a MSAT Engineer to lead the design transfer process for new products and product changes, working closely with R&D, Manufacturing, and other supporting functions ensuring a seamless transition and adherence to design control requirements and that product design specifications are met.

The MSAT Engineer will also collaborate with Manufacturing (in-house and external) to develop and optimize manufacturing processes, including the development of operating procedures and training programs while ensuring engineering principles as well as international and industry standards are met.

The MSAT Engineer will select, develop, and qualify capable manufacturing and laboratory technology (processes, jigs, fixtures, etc.) including inspection methods in collaboration with vendors and contract manufacturers to meet manufacturing and supply chain demands.

This position has a Monday \xe2\x80\x93 Friday, 8am - 5pm work schedule and is located at our Kingston, ON site.

Key responsibilities:

Technical Transfer

• Acts as a subject matter expert for all aspects of design transfer, providing guidance and support to cross-functional teams as needed
• Participates in the development of new products or product changes, providing input on manufacturability and scalability and to ensure timely development of product manufacturing concepts and equipment layouts
• Develops and maintains detailed project plans and timelines for design transfer activities, ensuring alignment with project goals and milestones
• Identifies and troubleshoots process issues, working closely with cross-functional teams to resolve any issues that arise
• Performs process gap analysis using risk analysis tools such as PFMEA and authoring gap analysis reports
• Supports process qualification validation activities as needed
• Supports improvement of MSAT structure and process
• Demonstrates sound knowledge of cGMP, GLP, ISO 9001, ISO 13485, IEC 62304

Investigations

• Supports 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 and Document Management Systems (DMS) to document manufacturing processes, investigations and technical studies
• Manages related Change Controls/Deviations/CAPAs following Lonza\xe2\x80\x99s SOPs and Quality Systems tools and acts as SME during internal and External audits

Continuous Improvements

• While continuous monitoring of GMP processes, uses statistical analysis to identify opportunities for improvement such as reducing process variability, streamlining manufacturing processes, increasing 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
• Is 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.
• Performs other duties as assigned

On Floor Support

• Provides technical assistance to Manufacturing, Supply Chain and Service for critical operations that require specific knowledge going beyond routine manufacturing operations (e.g., new processes, new procedures).
• Maintains and improves technical transfer documentation to support smooth introduction of new or modified equipment into production.
• Serves as technical contact for development of projects with R&D and Sustaining Engineering

Key requirements:

• Engineering or Science degree or equivalent required.
• 5 years of experience from a related regulated industry required
• Excellent Manufacturing technology skills and knowledge required
• Experience with validation/qualification and database required
• Sound knowledge of cGMP, GLP, ISO 9001, ISO 13485, IEC 62304 required
• Must have high attention to detail
• Able to translate opportunities into workable solutions
• Must be able to demonstrate strong business awareness
• Strong computer skills and proficiency in written and verbal communication required; SPS experience preferred
• Strong analytical and problem solving skills coupled with the ability to work independently and collaboratively in a fast-paced, team-oriented environment
• Excellent communication skills, with the ability to effectively communicate complex technical information to a variety of audiences.

Every day, Lonza\xe2\x80\x99s 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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