In this important role the Production Team Lead will oversee and support the product integration, performance testing, and release testing from both our internal team and CMO partners, by providing support and advice to remain compliant with the regulatory requirements (ISO 9001, ISO 13485, GMP, FDA) necessary to meet the production plans.
- Leading a highly skilled team of technicians, working within a matrix organisation, you will ensure production forecast is achieved by actively managing available resources, being hands-on when required, and actively communicating with relevant business partner;
- Ensure Instrument and Consumables production plan is achieved on time
- Support manufacturing process improvements and new product and process transfers to CMO
- Ensure production, batch records, quality deviations and training documents are accurate, updated and compliant with relevant regulatory requirements
- Collaborate and lead continuous improvement activities of the Production and Quality Syste
- Support the collection and analysis of site aligned manufacturing metrics to attain production goals
- Assist with the development of manufacturing related SOPs, WIs and other quality documents as needed
- Assist with initiating and/or reviewing investigations, deviations, nonconformity reports or other exception-based reports as needed.
- Hire, develop and train new and existing personnel ensuring an “audit ready compliance” mindset
- Ensure proper housekeeping and maintain cleanliness of the working area
- Follow, promote and improve the safety practices of the work area
- Able to work in a fast paced and open communication environment
You've Got This Covered:
- 3+ years’ experience in scientific/industrial complex electromechanical products assembly, with proven experience in GMP,FDA, ISO 90001/13485
- Previous experience in the biotechnology/biomedical industry is an advantage
- Experience of working with fluidic and opto-mechanical systems is desirable
- Must have the ability to adapt to rapidly changing priorities and flexibility to support operations in meeting the build plans.
- Strong understanding of manufacturing methods & terminology
What you can expect from us:
- Competitive salary
- 25 days holiday
- Flexi hours
- Pension scheme
- Share option scheme
- Group Income Protection
- Group Life Assurance
- Cycle to work/ Tech schemes
- Wellbeing initiatives
- An inclusive team environment where your contribution will truly make a difference
Interested to know more? Please send us a copy of your CV to firstname.lastname@example.org and we'll be in touch shortly.