Ensuring equipment used within Operational areas is fully functioning to required Safety, Product Quality and OEE levels and does not impact delivery.
Support Operational Projects by leading equipment commissioning through FAT and SAT.
Lead B2E Asset management across Operational areas, (Implement new systems where required) to include TPM to OEM recommendations, critical spares inventory, CILs and action plans created to show implementation and delivery.
Train process scientists and process technicians where required to implement processes, tooling jigs, and fixtures for projects.
Support operational technical aspects of new product development from concept to implementation and sustainment at the required scaled Production output levels and understand capacity requirements and implement engineering solutions, this includes the production of relevant validation documentation such as User requirement specification and functional specifications.
Design, implement and sustain effective Process Controls and Design for Manufacturing protocol using a variety of lean management tools and techniques and be able to train associates to create and understand documents/concepts effectively.
Verification and sustainment of production technical specifications and support documentation required to ensure the precise manufacture of all products i.e. Technical Spec Documents, Process control limits, Critical Process Control points, Line clearance protocols, etc. and clear communication /linkage to improvement/project.
Assess operational associates’ competency to operate equipment in safe/compliant manner and train CIL's so operator can complete.
Deputise for the department manager and represent operations at program meetings.
Risk management and mitigation plans to an agreed timeline with cross site communications.
Relevant proven track record in implementing effective Process Control procedures
Proven track record in implementing TPM, PPM and conducting RCA on Equipment
Experience of working a high value, low volume production environment
Proven experience of working within a highly regulated manufacturing organisation e.g. Pharmaceutical, Food, FMCG, Fine Chemicals to GMP standards
Knowledge of Change Controls, Deviations, Validation and CAPAs is advantageous.
Ability to work both as part of a team and as an individual for extended periods of time
Experience of working in the biotechnology section with prior knowledge of medical device manufacture would be advantageous
An awareness of ISO 9001, ISO13485 or CGMP processes.
Proven track record of leading Continues Improvement projects
Knowledge of CAD (Solidworks) and PLC Software (Allen Bradley, Siemens, BRX)
Strong influencing skills and ability to create good, cross functional working relationships
Process control driven approach
Strong statistical and analytical skills
Logical thinker with meticulous attention to detail
Strong communications skills with an ability to work at different levels of organisation
Good working knowledge of Chemistry
Excellent report writing skills
Education List of Education, Certifications, Training
A Science or Engineering based degree is desirable
Relevant experience gained within a production environment
Travel % of Travel, include approximate overnight stays per week
Travel expectations within this role are minimal (
This role shall be based at Newcastle upon Tyne
This role reports into the Process Development Manager.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.