Senior Project Engineer
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| Job Type | Contractor |
| Area | Waterford |
| Sector | Engineering |
| Start Date | |
| Advertiser | David Connolly |
| Job Ref | 1002990 |
| Job Views | 873 |
- Description
- Senior Project Engineer
Team Horizon is seeking a Senior Project Engineer for a leading Pharma company in Waterford.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
You enjoy working on exciting projects and want to work with a Pharma manufacturing site in Waterford.
Excellent contracting rates on offer
What you will be doing:
Managing small capital projects.
Compling at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements.
Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Ensure safety management is paramount in project delivery processes.
Lead by example and take ownership of EHS matters in relation to engineering activities you are involved in.
Ensure all work carried out is in compliance with the required standards, conforming to company policy, cGMP, SOP and regulatory guidelines.
Lead by example and take ownership for quality compliance in relation to engineering activities you are involved in.
Ownership of equipment qualification and process validation from a quality compliance perspective.
Lead in the development of project charters and scope definition.
Lead in the management process/schedule and facilitate project team meetings as required.
Ensure project methodology is clear and integrated into the project from initiation onwards.
Ensure documentation, training and handover meet the internal customers’ expectations.
Write, execute and review documents as required by the projects.
Liaise with contractors/customers when external resources are required to complete project works, acting as site contact.
Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure project activities are planned and executed in line with applicable deadlines.
Assist with submission/audit/deficiency responses activities when required, in a timely manner.
Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
Develop testing strategies and rationale for equipment/facility/system qualification.
Provide technical support/troubleshooting for equipment/facility/system issues.
Investigate/resolve deviations associated with project activities.
Utilise structured problem solving in support of project issues & problem resolution.
Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest.
Develop relationships with contractors, ensure they understand our business and are compliant to site procedures.
And any other duties as assigned.
What you need to apply:
Qualified to a minimum of degree level in an Engineering discipline.
5+ years’ engineering experience working in an oral solid dose pharmaceutical manufacturing and/or packaging (or comparable) environment.
Previous project management experience and/or qualification is a distinct advantage.
Knowledge and experience in Computer Systems Validation is a distinct advantage.
Knowledge of processes, equipment, facilities. systems used in pharmaceutical manufacturing.
Problem solving skills.
Experience in integrating in and leading cross functional teams.
Knowledge of cGMP, EU Annex and GAMP requirements.
Understanding of integrated validation approaches.
Ability to manage multiple conflicting demands and to priorities accordingly.
Focus on supporting internal & external customers in a safe and compliant manner.
Motivating others positively.
Ability to work independently and in teams.
Be driven by task / project and will show flexibility to ensure results are achieved.
Thinking ‘outside the box’
Self-starter and accustomed to setting personal goals.
CSV & automation knowledge is a distinct advantage
