Headquartered in Elstree, Herts, BPL part of Kedrion, are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.
Bio Products Laboratory manufactures pharmaceutical products derived from human blood plasma. These products are used to treat patients for conditions such as immunodeficiencies, coagulation disorders and critical care (blood volume deficiency).
We currently have an exciting opportunity for a Production Engineering Package Lead, on a fixed term contract until April 2025, to join our Engineering team located in Elstree, Herts.
Please note our site is not easily accessible by public transport so please take this into consideration when applying.
The main purpose of your job role will be;
* To provide the programme with the leadership for the delivery of the technical equipment work packages. Lead and support the production engineering elements associated with the equipment.
* To have the ability to digest complex project information from various sources, reassess and effectively advise stakeholders on project and process implementation strategy. It is required to use prior experience gained through working within a relevant role and apply to the project the requirements to fulfil the creation and implementation of processes and procedures to allow routine operation, maintenance and calibration strategies.
* These processes and procedures will include but are not limited to GMP documentation, H&S documentation and Risk assessments, designing of layout fit for operational use, maintenance and calibration. Ownership of project related activities and tasks as delegated by project manager and foreseen tasks from prior experience.
* To identify and effectively manage risks foreseen by continual improvement processes. Timely escalation of risks identified with suitable solutions identified to programme management will be expected.
* To be accountable to the Programme Manager or assigned line manager within the Project management team and responsible for the delivery of assigned tasks and project deliverables relevant to their specific discipline.
Key Duties and Responsibilities will be;
Project Task Management
* Responsible for managing assigned tasks projects to agreed deliverable timelines.
* Occasionally Lead cross functional team meetings to produce tangible, deliverable and collaborative actions to complete project tasks.
* Effectively apply prior BPL or other relevant experience and competencies to this role.
* Generate appropriate documentation relevant to the production role, for example but not limited to SOPs, maintenance procedures and records, GMP and H&S risk assessments and forms as required.
* Manage time effectively to achieve deadlines agreed as not to negatively impact the overall project timelines.
* Identify, escalate and problem solve any risks to GMP, H&S and project timelines in a timely manner. Use of prior experience and known needs for the implementation of new processes is expected. Utilise the escalation process where necessary.
* Provide regular project updates to stakeholders and other team members in weekly meetings and make use of visual boards and systems.
* Participate in meetings to ensure designs of the equipment, work flows and working areas created are suitable to your role and that of production engineering support activities.
* Ability to manage work load, participate with and support others within the project team is expected.
* Ensure project documentation reviews, creation and implementation are complete, current and stored appropriately on the shared drive or within the controlled document systems at BPL.
* Create and ensure accuracy of Asset trees in management systems used at BPL to allow suitable record keeping of asset management.
* Create, implement and train other engineers on maintenance processes produced for this project.
* Communication with internal and external stakeholders and suppliers is required to achieve task or project specific outcomes.
* Contribute to other team members and processes such as Site Engineering, Validation activities, Production process designs, continual improvement. This is not exhaustive but are expected as a minimum.
Communication
* The post holder will be an excellent communicator across all levels within and outside BPL. Correspondence will take the form of both written & oral methods, occasional presentations and reports.
* Ensure all project tasks and actions have an up to date status for communication and escalation, risks and issues are identified and added to a team tracking system with appropriate ownership and target dates assigned.
* Participate and contribute to regular prescheduled meetings.
* Escalate project risks and issues in a timely manner to ensure conflicting priorities and/or unforeseen barriers are highlighted and possible solutions or improvements identified.
* Keep project team informed of changes within the organisation or project tasks delegated that may impact on other project activities.
* Tactful communication of difficult / sensitive information. Deliver engaging, informative, well-organised presentations.
Technical Understanding
* Relevant prior experience is required to be successful in this role.
* Working knowledge of pharmaceutical GMP production is required to fulfil this role. Experience and competency in working with maintaining and calibrating production equipment used to manufacture sterile product is required, these may include, working in GMP classified clean rooms, Vial washer, Sterilising Tunnel, Isolators, Filling lines, Freeze Dryers.
* Process Equipment knowledge mentioned, contamination control processes and procedures understanding.
* Understanding Facility design, Equipment required and new technologies for implementation is highly desirable.
* Good understanding of Validation requirements of new equipment and clean rooms systems is desirable.
* Experience and competence in GMP and H&S systems for example creating of documentation in Trackwise and Controlled change in Trackwise (demonstrated) is required.
* Maintenance of machinery and calibration processes is required
* Ability to learn and apply leaning timely is key to the success of this role and project and is required for this role.
Financial Management
* It will be expected to obtain budgetary quote information for equipment and or materials required for the implementation. This may involve speaking with potential suppliers and guidance will be available to assist with information obtained.
* Time sheets may be required for work performed on the project outside of the post holders budget department.
Line Management
* No direct line management responsibility, unless willingness and competency to do is is displayed in which case a contractual change form will be arranged.
* Provide support to project team members regarding project management documentation and tools in accordance with BPL project management methodology.
IT
* Responsible for preparation, maintenance and security of all project information and documentation.
In return we offer -
* Competitive salary, and benefits to include a performance related bonus
* Pension
* Life Insurance
* 25 days holiday
* On-site parking and a subsidised restaurant
Please apply today for immediate consideration.