|Job Ref: 02661||Recruiter: Paul Sinnott|
|Country: Ireland||Location: Dublin|
|Job Category: Process, Pharma Life Science,||Salary Range: €Negotiable|
Pharmaceutical Manufacturing / Production client in South West Dublin.
To work 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.
Will have a 3rd Level Qualification Engineering Qualification with a minimum of 5 years experience / minimum 3 years pharmaceutical Manufacturing / Production Plant experience.
Be a strong communicator, passionate and enthusiastic in your way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.
The primary tasks of the role include:
To 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.
ROLES 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, haz-ops, 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 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, 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 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 Q.A 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, 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.
Ideally candidates will have experience of the following:
· Sterile Processing – 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
For further information or to apply please contact: Paul Sinnott Recruitment Consultant at kppm in Dublin on 086 043 8665 or Email
or email email@example.com