- A vacancy exists for a P5 Project Engineer within the Technical Services Department in reporting to the Engineer Project Manager.
- You will be working within cross-functional teams with a high-level of autonomy; playing a key role in Schedule Preparation, Pre-Planning and Resource Forecasting along with Project Management of Opex and Capex Projects on site.
- You will lead projects, taking the role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
Core Duties and Responsibilities:
- To liaise with the project requester and define exactly the project brief.
- To liaise with customer department as well as other Business Unit departments and support departments as required such as EHS, Tech Services, and Logistics etc.
- To attend regular planning meetings as required to ensure plant downtime is agreed.
- To make justifiable decisions at all times which will not compromise quality, capacity, flexibility, operability, security or EHS compliance.
- To immediately report to the Engineer Project Manager any deviations from the project plan which would have an impact on quality, specification, programme or cost .
- To ensure that adequate training is provided to Production and Engineering personnel, and to assist in any way that is practical.
- Chairing of design review meetings, site meetings, HAZOP’s, project meetings etc.
- To ensure that Project are handled and managed using the ’team’ approach.
- Ensuring that the Engineer in particular and the Department as a team are kept up to date in current engineering technology and work practices by attending, with approval, relevant seminars, exhibitions, training/educational courses and by reading engineering literature.
- To follow up snags ensuring that the project is completed fully, before closing the Capital Account.
- To communicate effectively within the Department Function and particularly with the customer.
- Ensure that all procedures described in the Department SOP’s or WI’s and Guidelines are strictly adhered to.
- To ensure that plant hand over, including the preparation of documentation packages is carried out in a controlled and punctual manner as per company procedures.
- To plan, manage, co-ordinate and design the ’front-end’ design of the project whilst evaluating quality and value relative to practicalities.
- Preparation of equipment specifications, budget estimates, scope documents, IA submittals, purchase requisitions, cost control data sheets, meeting minutes and circulation of same.
- To prepare installation specifications as per Standard Procedures and to complete AWP’s for all work.
- To oversee and control CAD services to ensure drawings are registered, prepared, checked, approved, circulated and controlled as per SOP for ’Registration and Control of Engineering Drawings’.
- To act as safety lead in line with construction regulations 2013 and appoint PSDP and / or PSCS as required. Also, to ensure EHS risk assessment carried out and actioned prior to capital submittal.
- To liaise with appointed external consultancy practices as directed, ensuring that the consultant operates to company procedures within a team framework.
- To source, select, procure, inspect, approve and oversee installation of equipment, machines and systems.
- To ensure that current regulations, standards and work practices are adhered to for all project work, i.e. FDA, HSA, HPRA, EPA, British Standards, USP, ETCI etc.
- For engineers managing direct impact projects they must carry out the commissioning and qualification phases as per SOP_002492.
- To liaise with QA Compliance ensuring that regulatory and validation issues have been addressed in an approved manner.
- To follow up on qualification deviations.
- To manage and control contractors working on site, ensuring that work practices comply with the relevant sections of the 2013 Construction regulations, company standards and cGMP.
- To ensure decisions, work practices or use of certain contractors do not expose the company to the risk of an industrial dispute.
- To ensure that training records are adequate and kept up to date.
- Ensure that change control procedures are strictly adhered to.
Minimum Qualifications and Experience:
- 3rd Level Qualification in an Engineering discipline
- For Engineers working on ‘Direct-Impact’ projects, they should have minimum 3 years pharma experience, and 5 years total experience.
- For Engineers working on ‘Indirect – Impact’ projects, they should have minimum 5 years’ experience.
- Sterile Processing experience – Bulk and Filling Operations.
- Good understanding of sterility requirements/environmental monitoring requirements.
- Grade A/B environment/exposure.
- Good understanding of aseptic techniques and technology.
- Cleaning Validation CIP/SIP (Stem in place).
- Media batch experience/incubation.
- Understandings of Autoclave technology.
- Strong documentation skills.
- Good Understanding of Regulatory requirements.
- Audit Experience.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178