Manufacturing Specialist I B

United Kingdom; Maidstone; On-site; GBP 32,000 - 42,000; Full time

Job summary

Sekisui Diagnostics in Maidstone, Kent, is seeking a Manufacturing Specialist I to analyse production data, plan manufacturing activities and support continuous improvement. The role involves equipment commissioning, validation, change control, QA support, and executing root cause analysis with a focus on quality and safety.

The candidate will work across multiple departments, liaise with suppliers, and lead improvement projects while maintaining cGMP compliance and robust HS&E practices in a

Qualifications

• Significant experience in large-scale manufacturing processes (fermentation, downstream processing and/or chromatography).
• Experience with ISO 9001/45001/14001 management systems is beneficial.
• Strong communication skills and ability to collaborate across teams.
• Proactive approach to continuous improvement and problem solving.
• Ability to work independently while contributing to team objectives.
• Experience in a cGMP-regulated manufacturing environment is desirable.
• A degree in a relevant scientific/engineering discipline is advantageous.

Responsibilities

• Collect and analyze production data using established methods to monitor process performance and identify trends.
• Plan manufacturing activities to optimize resource use and support continuous improvement.
• Coordinate equipment commissioning, validation, and change control processes.
• Support QA activities, deviations, CAPAs, and regulatory compliance.
• Lead risk assessments, root cause analysis, and improvement projects across the facility.

Skills

Fermentation

Downstream processing

Chromatography

cGMP experience

Data analysis

Cross-functional collaboration

Process optimization

Education

Degree in science/engineering

Job description

We have an exciting opportunity for a Manufacturing Specialist I to join our Production team based at Sekisui Diagnostics, Maidstone, Kent.

The successful candidate will be responsible for collecting and analysing production data using established scientific and statistical methods to monitor process performance, identify trends, and highlight potential concerns. The role will involve planning manufacturing activities to ensure the optimal use of resources, supporting continuous improvement initiatives, and working collaboratively across multiple departments.

In addition, the Manufacturing Specialist I will liaise with suppliers, support the procurement of new equipment in line with company procedures, and manage elements of equipment commissioning, validation, change control, and procedural updates. The role will also support manufacturing investigations, quality impact assessments, out-of-specification events, and deviation reporting, while exercising sound Quality and Health, Safety & Environment (HS&E) judgement.

The successful candidate will lead risk assessment and root cause analysis activities and coordinate improvement projects, including facility shutdown and start-up activities, working closely with stakeholders across the business.

Key Responsibilities may include

• Support Quality Assurance (QA) activities, including deviations, CAPAs, change controls and User Requirement Specifications (URS), while maintaining compliance with company and regulatory standards.
• Support Health, Safety & Environment (HS&E) systems, including risk assessments, incident reporting and investigations.
• Troubleshoot manufacturing and process-related issues using scientific and technical expertise to identify root causes, optimise performance and implement effective corrective actions.
• Collaborate with Engineering and Maintenance teams to resolve equipment failures and improve asset reliability.
• Support routine large-scale manufacturing operations, including fermentation, downstream processing and chromatography, as required.
• Assist Logistics with manufacturing planning activities and inventory management.
• Support Technical Operations with the transfer of new products from Process Development into Manufacturing.
• Assist the Validation team with equipment, process and cleaning validation activities.
• Support management with Engineering Project Requests and manage capital investment projects in partnership with the Engineering & Maintenance Department and Production Manager.
• Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) for new equipment.
• Take ownership of the upkeep and continuous improvement of Production areas and equipment.
• Support Production and QA teams with the review and closure of batch records.
• Act as a training resource, supporting the development and cross-training of colleagues.
• Identify, recommend and implement continuous improvement opportunities through Kaizen initiatives.

We are looking for a motivated and collaborative individual who thrives in a fast-paced manufacturing environment and can effectively manage multiple priorities.

The successful candidate will have:

• Significant experience in large-scale manufacturing processes, including fermentation, downstream processing and/or chromatography.
• Experience working within ISO 9001, ISO 45001 and/or ISO 14001 management systems.
• Strong communication skills, with the ability to build effective working relationships across teams.
• A proactive approach to continuous improvement, problem solving and personal development.
• The ability to work independently while contributing positively to team objectives.
• Experience within a cGMP-regulated manufacturing environment is highly desirable.
• A degree in a relevant scientific, engineering or technical discipline would be advantageous.

Who we are:

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.