- The Project Engineer is responsible for the management and execution of site projects within the sites aseptic filling manufacturing areas.
- The successful candidate will be responsible to ensure the full lifecycle of projects (conceptual design, feasibility studies, basic design, detailed design, procurement, construction management, commissioning, testing, qualification, handover) are managed in a professional manner in line with Good Engineering Practice and site procedures.
- This role is initially a 12 month contract, however there is a strong possibility this will be extended.
Core Duties and Responsibilities:
- Execution of site projects within the sites aseptic filling manufacturing areas.
- Develop and maintain project management system for aseptic filling manufacturing areas (e.g. procedures, guidelines, policies, specifications).
- Work closely with the technical operations manager to define, prioritise, and develop projects plans, including setting deadlines, prioritising tasks and deliverables.
- Evaluate projects to ensure they are meeting company standards, adhering to budgets, and meeting deadlines
- Ensure that all personnel (including consultants and contractors providing services on site) adhere to all statutory, regulatory and site requirements (e.g. site policies, procedures, standards, guidelines, etc.).
- Manage project spend tracking, monthly reporting and forecasting.
- Manage project approval progress tracking, monthly reporting and forecasting.
- Interfaces with ‘end users’ Manufacturing, Facilities, Validation, Maintenance and Quality internally.
- Interface externally with external engineering consultants, major equipment vendors and Corporate Engineering
- Development and/or review of URS for process and automation systems. Lead and co-ordinate equipment vendor FATs ensuring acceptability of plant and documentation prior to site delivery.
- Play a key role in the review, approval and execution process of Engineering and Validation lifecycle documentation.
- Lead NPI projects.
- Coach wider team on process knowledge, chemistry and build mastery among team.
- Remain current on state-of-the-art for systems, and for the appropriate adoption and use of new techniques and technology on site.
- Represent the site with outside firms, technical societies, standards organizations and regulatory bodies.
- Oversee the development, revision, review, and approval of Standard Operating Procedures that are owned by Technical Operations department.
- Develop metrics to support procurement strategies for equipment, inventory management, spares and preventative maintenance.
- Incorporate lessons learned from field and industry into standards.
- Ensure adherence to standards and good engineering practices.
- Use their network to provide engineering support to the commissioning team, to resolve escalated technical issues and conflicts, as required.
Minimum Qualifications and Experience:
- Degree in Chemical Engineering, Process Engineering or associated Discipline.
- Significant engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, Oral Solid Dosage, CIP/SIP, Clean Utilities, utilities, HVAC, Packaging and Devices.
- Ability to read/interpret engineering drawings and design documents.
- Management of medium to large size projects.
- Excellent technical writing and verbal communication skills.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
- Good technical knowledge with excellent project engineering principles i.e. all phases of project life cycle – URS through to hand-over.
- Fluent in the needs of validation FAT to PQ (protocol generation, review, execution and reporting).
- Knowledge of cGMP/GAMP requirements.
- Experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, deciding cost/benefit analysis).
- Strong communication, relationship building, leadership and mentoring skills.
- Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
North Valley Business Centre, Cork, T23 KC67.
+353 21 206 6178
Please note, we do not require agency assistance with this role.