Site Name: UK - Hertfordshire - Ware
Posted Date: Feb 7 2025
The Engineering function at the GSK Ware Manufacturing and Supply site is responsible for the provision of technical expertise to support the manufacturing, automation and controls systems for all production operations to ensure production targets are achieved.
The Compliance Engineering Manager is accountable for ensuring safety and quality of all engineering activities conducted across the Ware campus (with the exception of EHS and R&D Operational Engineering and Lab areas). This role is accountable to the GSC Site Engineering Director for maintaining compliance with relevant GSOPs, Engineering Standards and Statutory regulations. You will implement and lead Engineering Governance processes and ensure they are carried out effectively. Utilising a high level of engineering knowledge and credibility you will represent engineering in audits (of any level), whilst ensuring engineering process owners remain accountable and that the site carries out its duties (whilst remaining compliant, safe and adherent to engineering GMP). The Compliance Engineering Manager is the main link to above site and other site engineering functions and is a key driver in standardisation and adoption of best practice and new technologies.
Key Responsibilities:
• Responsible for assurance of all aspects of compliance relating to the Engineering Organisation.
• Ensuring ownership of engineering standards is defined and that process and standard owners conduct their duties to remain compliant with all relevant legislation, Engineering Standards and Global Alerts.
• Engineering oversight of applicable of engineering standards and statutory legislation at GSC Ware. They must have the engineering knowledge to understand all ESs, critique updates, conduct gap analysis, risks assessments and generate effective mitigation plans linked to these. Rapid and accurate assessment of engineering alerts for pertinence at GSC Ware, evaluate risk and decide on appropriate mitigating actions. Role holder needs to be able to challenge site Engineering Technical Authorities across any area of expertise.
• Facilitate and manage the Engineering Quality and Engineering EHS councils.
• Process and engage with Site Quality organization to ensure engineering components in the Quality Risk Model are in control.
• Accountable for the deployment of contractors (working on behalf of Engineering Compliance) to ensure they are both safe and compliant with GMP and environmental standards and adheres contract management policy (takes into account the expectations of the local community).
• Process ownership of Contract Management policy for Engineering and for the site technical drawings to ensure they meet ES and compliance requirements
• Accountable to the Operational Engineering Manager for the delivery of Calibrations expertise and Cal Lab service to the Operational Engineering and Laboratory Teams
• Responsible for maintaining records to demonstrate engineering systems are compliant with appropriate internal and external GMP regulations relating to Engineering Operations including Engineering Supplier management, management of the Engineering self-audit process (L1) and TP13 Audit requirements.
• Responsible for the governance of Engineering Key Performance Indicators (KPIs), driving metric improvements and maintenance of Engineering Data in the ERP/CMMS systems including RMS and Site Change Control.
• Role holder will govern the Authorised Person List (GSC Ware Engineering Technical Authority Register and Duty Holder Register) and therefore must have an good understanding of related ESs and requirements of an Authorised Person. Role holder will identify gaps in knowledge and capability of ETAs and facilitate improvement plans to mitigate against these.
• Management of the engineering compliance team and accountability for and oversight of, the responsibilities within the remit of those functions (Permit Officer and Compliance Lead, Platform Equipment Lead (Metrology))
• Lead problem solving for complex engineering issues from issue identification to root cause and remediation.
• Maintain strong network across GSK to ensure shared learning and application of best engineering practices and latest technology.
• Site PCCE specialist, responsible for deviation review and attendance at above site monthly COP.
About You:
This role would suit a motivated person who has strong experience of working in a project portfolio delivery environment. You will be a qualified engineer (to degree-level or via professional registration), with strong people-management skills, budget planning, contract management and control skills, and pharmaceutical expertise. You will drive common-thinking and be focused on providing solutions. It is also important to demonstrate strong partnering skills (both internal customers and external suppliers and contractors). You will also have strong knowledge and understanding of scientific/technical design and operation of pharmaceutical manufacturing facilities.
About Ware Manufacturing Site:
We are co-located with our R&D colleagues and recently opened a new, state-of-the-art oral solid dose facility at Ware. At this location our scientists, technicians and engineers (from R&D and Global Supply Chain – GSC) work collaboratively together (using the latest technologies) to rapidly knowledge transfer and deliver GSK’s most innovative, medicines faster and more efficiently. On site we produce over 60 million respiratory inhalers each year with growing demand in future years. The site also processes Active Pharmaceutical Ingredient (API) for use both on site and other manufacturing sites in our network.
CLOSING DATE for applications: Friday 21st of February 2025 (COB).
Basic Qualifications:
* Minimum of a Bachelor of Engineering (BEng) or HND and IEng.
* Relevant engineering / compliance experience gained from working within complex manufacturing engineering teams.
* Knowledge of and experience of working within highly regulated (GMP) environments.
Benefits:
GSK offers a range of benefits to its employees, which include, but are not limited to:
* Competitive base Salary
* Annual bonus based on company performance
* Opportunities to partake in on the job training courses
* Opportunities to attend and partake in industry conferences
* Opportunities for support for professional development and chartership (GSK are accredited by IET, IMechE, IChemE and other professional bodies)
* Access to healthcare and wellbeing programmes
* Employee recognition programmes
If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK .
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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