We are currently seeking a Manager, Process and Technology to join our team. This role is critical in establishing, implementing and maintaining systems and/or services to measure and improve product quality as well as ensuring that manufacturing processes are efficient, effective and compliant with internal and external quality requirements.
The Manager, Process & Technology will manage the calibration, verification and maintenance activities under the LUMAC system (Log of Use, Maintenance And Calibration). You will lead the development and execution of validation programs as well as assist in the evaluation of new equipment, methods, components and processes as related to current and new market products.
- Facilitates implementation of new and/or revised quality systems processes
- Ensures manufacturing equipment and processes remain in a validated state by:
- Developing calibration and/or verification methods and procedures
- Developing maintenance schedules and procedures
- Leading the resolution on much of the equipment discrepancy reports
- Overseeing maintenance and calibration on production equipment via the LUMAC system
- Overseeing repairs on major pieces of equipment (e.g. water purification, compressed air, labeler, and etcher)
- Reviews, prioritizes, evaluates, initiates and facilitates changes relating to maintenance and calibration procedures
- Participates in the evaluation of new equipment, components and materials used in manufacturing process (i.e. vial changes, tubing, etc.). This may include creating experimental plans, writing protocols, conducting experiments and reporting results.
- Assists with creating process maps of new and existing processes
- Plans, schedules and organizes validation projects for new and existing areas, including manufacturing processes, cleaning and equipment, etc.
- Prepares process validation protocols and process maps. Initiates and executes validation protocols throughout the facility.
- Interfaces extensively with the QC/QA, Production and Manufacturing departments to identify projects and problems requiring validation support
- Develops, creates, reviews and/or approves User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and other layout or process design activities
- Develops, writes and/or performs Site Acceptance Testing (SAT), Factor Acceptance Testing (FAT), commissioning and other experimental activities
- Develops and implements all necessary Standard Operating Procedures for validation of manufacturing processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and requalification of critical systems, utilities and production processes
- Writes validation summary reports that present, summarize and offer conclusions on the validity of the process based on the results of analysis
- Coordinates the facility qualifications program by preparing the protocols, monitoring the execution, auditing the results and assisting production in resolving any identified problems.
- Assists with risk assessments
Professional Knowledge & Skills:
- FDA 21CFR820
- Detailed knowledge of ISO 13485 and ISO 14971
- Health Canada medical devices regulations
- CE Marking for IVDs/EU IVD regulations
- Skilled writer with ability to create comprehensive procedures, reports and correspondence for internal and external distribution
- Ability to coordinate numerous activities concurrently with minimal supervision
- Knowledge of technologically advanced and complex products
- University degree in Engineering or related field
- 3-5 years process validation experience preferably within an IVD setting required
- 5-10 years working within a manufacturing industry
Compensation will be commensurate with experience. If you’re interested in joining our team, please submit your résumé in confidence, along with compensation expectations.