- Delivery of new processing equipment to site based on planned timelines and scope. Processing equipment includes autoclaves, vial processing line, lyophilisers, isolators and stopper processing equipment.
- Delivery of necessary and significant upgrades to existing processing equipment ensure that equipment remain compliant to cGMP and EHS requirements.
- Provide leadership in developing project strategy for Biologics 2 facility.
- Engagement with other senior managers in Biologics 2 facility to ensure that there is close cross-departmental alignment.
- Participate in plantwide Quality system.
- Process GTW records for work on critical systems or deviations from critical systems.
- Participate in plantwide EHS program.
- Adherence to all site / corporate policies.
- Accountability for E&T team aligned to B2, ensuring that team have no overdue training items / GTW actions / EHS actions / etc.
- Oversight of B2 E&T projects ensuring that project scope is delivered within agreed timeline and budget.
- Manage project cash flow and set up and management of PO’s.
KEY/ACCOUNTABILITIES: Weight %
This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility
- Provide leadership in the development of an annual project master schedule for B2. Delivery of B2 projects based on planned timelines and scope. Management of capital budget for building. 50%
- Ensure team maintain in compliance with cGxP requirements. All GTW records are processed within required timelines, training records are maintained and up to date. Engagement with site quality initiatives (e.g. quality interventions, etc.) 20%
- Keep abreast of current engineering best practice working with the B2 cross-functional team to develop a plan to close any potential gaps. Provide support for audit preparation, direct audit interaction and involvement in audit responses. 10%
- Support and comply with internal EHS requirements, procedures and policies. Ensure continued conformance to the EMS within the department. Achieve the companies stated quality objectives through continuous improvement efforts and conformance to quality standards. Attend Departmental and AEPX meetings and participation in any Quality and Safety initiatives. 20%
Education and Experience/Knowledge:
- Relationship Building: establishing excellent working relationships with all functions within the business unit and QA team.
- Communication: excellent communication and presentation skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
- Planning & Organising: excellent analytical skills. Ability to plan and schedule.
- Decision Making: identify and understand issues, problems and opportunities whilst providing a viable solution.
- Adaptability; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
- Passion for results: – Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
- Receptivity to feedback – Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
- Culture fit: Have a people-centred approach to their work whilst upholding the values and ethos of our client.
Other requirements (i.e. travel)
- Undertake any training or travel that the role may require, including the completion of quality inspections of third-party contract facilities as required
COMPLIANCE AND INTEGRITY
You will be responsible for conducting your activities on behalf of the company consistent with a high standard of business ethics and in compliance with the laws and regulations that govern our activities
For a confidential discussion please contact Christopher O Toole.