Our client who are leader in revolutionary diagnostic led care solutions are going through a huge expansion in the manufacture of their life saving medical devices. They are looking for an Senior Process Engineer to join their facility based in Alloa or Eurocentral.
What's in it for you?
- Eurocentral or Alloa based (travel may be required between sites)
- Dayshift
- EXCELLENT Salary
- Opportunity to work with a dynamic and innovative company
- Permanent opportunity
As a Senior Process Engineer you will have an excellent understanding of all aspects of the product lifecycle and strong technical / scientific understanding of existing and new assay products. You will support product and process issues across multiple departments and review and support closure of quality events / non-conformances. Lead and execute validation and verification activities and documentation updates, as well as product and process characterisation activities. Lead Kaizen events and improve the mapping of processes, control plans and risk assessments to enhance productivity and quality. Support Equipment and Maintenance Engineers with design and development activities and leads a team of 4 or more engineers to deliver on business related goals.
Responsibilities:
- As a Senior Process Engineer you will have excellent understanding of all aspects of the product lifecycle and strong technical / scientific understanding of existing and new assay products
- Work closely with external suppliers to correct material issues / non-conformances
- Lead Kaizen events and mentor / train production team on continuous improvement initiatives to deliver manufacturing excellence
- Supports process / product issues across many departments (e.g. Manufacturing, Calibration, Packaging, Customer Complaints)
- Develops and improves mapping of processes, control plans and risk assessments to enhance quality and productivity
- Supports Equipment and Maintenance Engineers in the design and development of new tooling / equipment and / or fixtures
- Lead a team of 4 or more engineers to deliver on business related goals
- Review and support closure of quality events / non-conformances
- Leads process and product characterisation activities and identifies new methods of analysis
- Leads validation and verification activities, test method development and documentation updates
- Excellent understanding of scientific assay principles and product release testing / calibration methods
- Works cross-functionally in order to help deliver business goals (e.g. Product Support, R&D, Supply Chain)
- Implements new strategies to transform production site into best in class facility (e.g. cost reduction, health and safety, quality culture and work ethos etc.)
- Support internal audits and ensures highest levels of quality and compliance at all times
- Continuously review manufacturing documentation for accuracy and make updates using document change control
- Be open to self-development and training opportunities to enhance professional skillset
- Investigate, root cause and resolve non-conformances / quality events
- Good understanding of ISO 13485 and other related regulations
- Support internal audits when necessary
- Ensure changes to process and specifications meet quality standards and are documented appropriately
- Adhere to all relevant quality and regulatory requirements
Essential Skills:
- Experience of optimising product and processes within industry
- Excellent understanding of scientific assay principles and product release testing / calibration methods
- Demonstrates excellent problem-solving skills (e.g. thinking critically to make key decisions under pressure)
- Understanding of lean manufacturing principles and statistical analysis methods/techniques
- Proficient in use of MS Office, Powerpoint, data analysis software (e.g. Minitab, Excel) and CAD software
- Comfortable working with external suppliers and cross-functionally to deliver business goals
- Lead and execute validation and verification activities and ensures timely completion of associated documentation
- Drives manufacturing excellence through engagement / training of production team on continuous improvement initiatives and quality standards
- Technical engineering lead for process and product issues and ensures fast and effective closure of quality events / non-conformances
- Ensures highest standards of quality and compliance maintained at all times
- Excellent understanding of process and product characterisation methods and CTQs
- GxP experience
- Competent in documentation writing and presenting to key stakeholders
Please apply directly or contact Caroline Strachan cstrachan@weareninetwenty.com