Sekisui Diagnostics is in need of a Senior Controls Systems Engineer for its’ team in Maidstone, Kent.
You will bring your experience in leading and contributing to the Design, delivery, compliance and lifecycle management of GMP-compliant control systems. You will serve as a technical lead within the team for any process control issues generated by Programmable Logic Control (PLC), Environmental Monitoring systems, Supervisory Control and Data Acquisition (SCADA), and Human Machine Interface (HMI) systems. You will lead factory acceptance testing (FAT) and site acceptance testing (SAT)
To be successful you will have previous experience in a GMP environment with a strong understanding of validation and data integrity, Advanced PLC/SCADA expertise (Alan Bradley and/or Siemens). Ability to control several projects at the same time in a fast paced environment.
You must have the ability to read piping and instrumentation diagram (P&ID) drawings/specifications and challenge vendor approach.
In addition, you will:
- Automation Strategy & System Design
- Define and approve system architectures and standards
- Ensure full traceability from URS FDS SDS code
- Lead PLC/SCADA development and configuration activities
- Review and approve software design and implementation
- Ensure robust alarm management, interlocks, and fail-safe design
- Commissioning, Qualification & Validation Leadership
- Define validation approach in collaboration with QA/Validation
- Ensure systems meet regulatory requirements and validation standards
- GMP Compliance & Data Integrity Ownership
- Ensure systems remain in a validated state
- Lead audit readiness and interface with regulators/vendors
- Lead Engineering Change Control for automation systems
- Perform impact assessments for complex system changes
- Ensure lifecycle management of automation assets
- Provide technical guidance to engineers and technicians
- Support development of site automation capability
- Act as SME for control systems across the site
- Lead automation workstreams in capital projects
- Manage system integrators and vendors
- Interface with senior stakeholders across Engineering, QA, and Operations
- Define and drive automation improvement initiatives
- Support site digitalisation and integration strategies (EMS, historians, etc.)
- Improve system performance, reliability, and compliance
- Lead or participate in safety reviews, Failure Modes and Effects Analysis (FMEAs), HAZOPS, or similar
- Maintain records for regulatory purposes to current legislation, including Current Good Manufacturing Practice (cGMP) where required
- Support vendor cost negotiations/ challenge cost increases/ scope
- Ensure the maintenance team are educated on new equipment and involved to ensure successful handover of projects
- Facilitate continuous improvement workshops involving cross sectional teams
- Support regulatory and customer audits
If this sounds like you, please apply for immediate consideration.
At SEKISUI Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.
SEKISUI Diagnostics offers a competitive compensation and benefits package.
Equal Opportunities
As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online.
Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.
