Job overview
The purpose of this role is to provide a support service to the Division by ensuring the site is maintained in compliance with cGxPs, safe and secure. This includes aspects of infrastructure, facilities, utilities, and processes critical to the compliant and efficient operations of the Division.
This is a matrix role which requires the post holder to work closely with other stakeholders outside the Division to remain compliant with TRUST policies regarding facilities, security, HS&E and waste management.
Primarily reporting to the Head of Production, the post holder will be expected to work autonomously to:
- Line manage the HPS Domestic / Specialist Cleaning Team.
- Be the Division’s ‘go to’ for the site’s infrastructure, facilities and utilities.
- Maintain Divisional Health, Safety and Environment compliance.
- Work alongside and support the site Validation Lead to ensure cGXP compliance.
- Professionally engage and be the key point of contact with external contractors.
- Use judgement based on facts and analysis to coordinate and plan the Trust’s support departments to ensure that the needs of the Division are met supporting the efficient and continuous supply of medicines to patients nationally.
The HPS Domestic / Specialist Cleaning Team provides specialist cleaning of Grade D and C cleanrooms, general cleaning duties of shared communal areas / corridors as well as warehousing, offices and laboratory.
Detailed job description and main responsibilities
The postholder is responsible for:
- Facilities and Equipment
- Maintaining assets across the site covering equipment, utilities, and facilities.
- Organising, coordinating and ensuring the complex annual shutdowns are completed.
- Tracking overseas contractor activities on site regarding facilities and associated equipment.
- Maintaining details in the Asset Management System ensuring all records and documents are logged and stored.
- Ensuring all plant equipment, facilities and fabric are maintained and where applicable aligned with the validation master plan as defined by the HPS Validation Lead.
- Organising insurance inspections as required.
- Managing contractors and the site Passport / Permit to Work process relating to equipment, utilities, and facilities.
- Performing improvement works on facilities.
- Liaising and coordinating CHS Estates for all estates organised visits.
- Administering Service Level Agreements (SLA) for facility-wide equipment.
- Liaising with CHS Procurement and the HPS Validation Lead for renewal and specification for all service level agreements for plant.
- Performing daily checks within the facility.
- Logging and trending data collected for facility-wide equipment outside of validation oversight.
- Problem solving, fault finding and remediation where required, including on specialist equipment.
- Specific ownership of key critical equipment requiring in-depth expertise, e.g. WFI plant and HVAC.
- Overseeing and developing policies / procedures for site security including CCTV system.
- Being a member of the on-call team partaking in out-of-hours cover.
- Ensuring facilities cleaning activities are performed according to validated processes.
- Working within the clean area.
- Developing a Divisional facilities meeting, including safety, waste and security topics.
- Reducing the amount of production downtime due to equipment breakdowns and facility upgrade / repairs.
- Reviewing and developing policies / SOPs for maintenance, safety, cleaning and security across the division.
- Working with Trust Stakeholders to review their policies so they support and reflect the legislative requirements of the Division.
- Developing URS in relation to the procurement of equipment and building repairs / upgrades.
- Health, Safety and Environment
- Supporting the Division in developing and maintaining Process Risk Assessments.
- Coordinating with the Trust Lead and being the Division’s ‘go to’ for Health, Safety and Environment.
- Coordinating with the Trust Lead and being the Division’s ‘go to’ for Fire Safety.
- Coordinating with the Trust Lead and being the Division’s ‘go to’ for Waste Management.
- Ensuring that Health and Safety and COSHH regulations relating to facilities are adhered to.
- Ensuring manual handling of equipment, parts and materials is performed in accordance with good practice.
- Projects
- Leading major equipment/facilities projects linked to CAPEX using established Project Management systems, including planning, organisation, oversight, tracking, communication, execution and handover.
- Providing support for other projects in the Division as a Subject Matter Expert.
- Quality and Compliance
- Ensuring all maintenance activities are carried out in accordance with the principles of cGxPs in order that the quality and compliance requirements are met.
- Operating within the Quality Management System including change control, deviations and investigations and CAPAs.
- Owning relevant SOPs and being responsible for their accuracy, review, update and implementation, ensuring compliance with the latest regulatory expectations.
- Following defined SOPs relating to all aspects of work.
- Maintaining accurate records aligned with ALCOA++ principles.
- Participating in inspections and audits as a Subject Matter Expert.
- Ensuring data integrity requirements for cGMP are complied with during all aspects of work.
- Identifying and implementing continuous improvement of systems, processes, and equipment, considering advances in technology and best practice.
- Clinical Duties
- This role is deemed to provide a basic clinical technical service indirectly to patients in the manufacturing and delivery of medicines.
- Professional Duties
- Maintaining working competence in all areas of responsibility and exercising the knowledge and skill that can be reasonably expected based on the role and any relevant qualifications.
- Operating professionally and impartially.
- Declaring and avoiding any potential conflicts of interest created by the post.
- Managerial Duties
- Direct line manager responsibilities for the domestic / specialist cleaning team including holiday approval and oversight, appraisals and personal development, absence and performance management, training and competency.
- Direction and prioritisation of workload for the team.
- Recruitment of team members.
- Monitoring and reporting relevant KPIs, ensuring targets are being achieved and implementing remedial actions where necessary.
- Writing business cases and reports for the Senior Leadership Team to inform procurement, investment and organisational / operational structure decisions.
- Being responsible for the repair and maintenance of general equipment and systems.
- Contributing towards the preparation of the Divisional budget.
- Managing Self
- Working patterns are expected to be unpredictable and subject to frequent interruptions from internal and external stakeholders.
- Participating in regular supervision.
- Attending all mandatory training.
- Participating in appraisal at least annually, identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal.
- Complying with all Trust policies, procedures and protocols.
- Maintaining professional conduct and appearance.
- Exhibiting the values and behaviours expected by the Trust as part of ‘One Culture of Care’.
This job description is an outline only and is not definitive or restrictive in any way. It will be regularly reviewed and may be amended in the light of changing circumstances following consultation with the post holder.
Person specification
Experience
- Relevant experience gained in a GxP (Pharmaceutical or other healthcare product) regulated environment.
- Experience in the development and process around Fire Safety, Waste Management, Health and Safety and COSHH.
- Experience of working to deadlines and managing complex requests.
- Experience of supporting / leading quality and service improvement projects.
- Demonstrated experience of problem solving and critical thinking.
- Computer literacy including working knowledge of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, Outlook and Teams.
- Experience of dealing with confidential, sensitive (personally and commercial) information with tact and sensitivity.
- Evidence of practical experience of data analysis, interpretation and reporting.
- Development and creation of Process Risk Assessments.
- Relevant experience in the cleaning and maintenance of cleanrooms, laboratories and warehouses.
- Experience using electronic BMS and Asset Management systems.
Qualifications
- Degree or equivalent experience in building engineering or facilities management.
- Practical and theoretical knowledge acquired through diploma level or equivalent in facilities management.
- Leadership training (e.g. ILM, CMI) to Level 5.
- IOSH ‘Managing Safely’ qualification or equivalent.
Communication
- Experience of general team management, including recruitment, sickness management and disciplinary.
- Excellent interpersonal skills with the ability to engage with stakeholders both internally and externally, and at various levels of seniority.
- Good persuasive and negotiation skills, able to manage conflicts.
Training
- Ability to demonstrate commitment to ongoing self‑development.
- Ability to train others in processes, policies and procedures.
Practical/Intellectual Skills/Personal Qualities
- Team player.
- Able to use own initiative, prioritise workload and pay meticulous attention to detail.
General
- Must be able to be part of a rotating on‑call team able to reach site in under an hour when on call.
- Ability to work in various locations throughout the network of services provided by Calderdale and Huddersfield NHS Foundation Trust.
- Must be eligible to work in the UK.
Employer statement
Calderdale and Huddersfield NHS Foundation Trust are committed to equal opportunities and welcome applications from all sections of the community, regardless of any protected characteristics.
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