Engineering Supervisor (GMP)
Roslin Cell Therapies Limited
Location
Edinburgh | United Kingdom
Job description
Engineering Supervisor (GMP)
Location: NINE, Edinburgh BioQuarter
Who are we?
We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.
Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.
Find out more about what we do here !
Why join us?
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
- A generous salary package – we reward our people at the level they deserve.
- 31 days of annual leave, plus 4 public holidays which increases with tenure.
- A competitive company pension scheme to help you save for the future.
- Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.
Your new role
- An exciting opportunity for an Engineering Supervisor to join our successful Facilities function.
- This role will be responsible for leading a team in defining engineering procedures for the design, maintenance, qualification, validation, and calibration of laboratory manufacturing equipment and the wider facilities and systems in line with current Good Manufacturing Practice and business needs/requirements.
- Develop inhouse engineering and calibration processes and procedures, liaising with the validation department in support the creation of internal validation protocols for temperature-controlled equipment.
- Apply cGMP work practices and techniques during validation activities.
- Provide guidance and technical support to the Engineering team. Document reviews of logbooks, maintenance records, and associated GMP paperwork activities.
- Specialise in the maintenance and operation of cleanroom equipment, utilise expertise as a Grade B Cleanroom Qualified professional to maintain, tidy, and safe engineering areas.
- Maintain Grade B cleanroom qualification and adhere to the associated protocols and practices.
- Lead investigations into equipment-related deviations and implement necessary corrective actions. Ensure timely and compliant re-qualification / mapping of equipment, partnering with internal teams and third-party service providers, ensure accurate and up-to-date records.
- Ensure EMS systems are effectively administered, updated, and managed. Proactively identify and communicate areas for improvement to the Facilities Manager and relevant stakeholders.
- Liaise with internal teams and contractors, ensuring seamless communication and adherence to quality and regulatory requirements. Manage and coordinate repairs on-site, providing support and supervision for contractors, ensuring compliance with safety and quality standards.
- Conduct/oversee daily checks to maintain equipment functionality and identify, address, and escalate any issues promptly.
- Drive the resolution of Quality Management System (QMS), Change Controls (CCs), Deviations (DEVs), and Corrective and Preventive Actions (CAPAs) in a timely manner.
- Generate SOPs in line with RoslinCT standards, ensure consistency and regularly review for relevance and compliance.
- Identify and implement process improvement initiatives related to equipment maintenance and facilities management.
- Take responsibility for raising purchase orders and organizing timely deliveries for required materials and services.
- Be available for scheduled weekend work (if required) and provide out-of-hours telephone support as needed.
About you
- You will have experience in a team leader/supervisory position and experience within a GMP regulated environment.
- Extensive experience with equipment fault finding, calibration, and equipment qualification works.
- Knowledge and experience in using quality management systems relating to facilities and equipment.
- A good working knowledge of Good Engineering Practice and process improvement tools such as Six Sigma, Lean processes, and FMEA.
- Experience in total productive maintenance (TPM) led environment.
- Demonstrate proficiency with computer software, especially the Microsoft-365 suite.
- You will have the ability to be Grade B cleanroom qualified.
- You will take responsibility for setting high standards and looking at the bigger picture to recognise the impact of actions.
- You will have excellent written and verbal communication skills with the ability to partner with colleagues across all departments.
- Excellent organisational skills with the ability to multi-task in a fast-paced and dynamic environment.
Qualifications
- An appropriate engineering/scientific qualification with substantial, relevant industry experience i.e. within a GMP manufacturing operation.
Next Steps
If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.
At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.
We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.
If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [email protected] . We’re here to assist and make things as smooth as possible for you.
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