Looking for an experienced project engineer with 6+ years of experience in pharmaceutical manufacturing. Strong GMP & documentation experience, budgetary exposure, people management, CAD knowledge, and facility upgrade/install experience is desirable.
The Company
The client is a pharmaceutical company located in Dublin, Ireland with 70+ employees. The client develops and manufactures innovative patient friendly pharmaceutical products for international markets. They are now seeking an experienced Project Engineer as they expand and broaden their range of non-sterile oral products.
Main Goals within this role:
Manage site work activity for Projects in the R&D, Manufacturing and Facilities across our operational footprint.
Manage all service contractors, on project related works and general routine visits from vendors when required.
Design, implement good standard practices for projects and use innovation and sustainability engineering practices to bring project to fruition.
Responsibilities
Engineering
- Provide process engineering support to production teams and projects
- Manage junior engineers and encourage best practice engineering and quality systems.
- Develop and support new manufacturing processes and technologies
- Manage Project budgets and timelines and produce monthly engineering project reports to Engineering manager.
- Understand equipment operation in detail
- Support project delivery through FAT, SAT and IOQ involvement as needed
- Identify means to improve processes, increase efficiencies and reduce costs
- Strong focus on disciplined root cause analysis
- Liaise with vendors and contractors.
- Monitor process risks and ensure mitigations are in place as required.
- Benchmark other industries and organizations to ensure best practice is in use.
Health, Safety and the Environment
- Always comply with the Health, Safety and Environmental policy and associated procedures.
- Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Quality Compliance
- Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines.
- Take ownership for quality compliance in all activities under the responsibility of the role
Qualifications
- Qualified to a minimum of Degree level in engineering or related discipline
- Project Management Qualification
- Minimum 5 years of Process/Project Engineering experience within a relevant Pharma or FMCG environment
Skills and Behavioural Competencies Skills
- 21 CFR Compliance
- Pharmacopoeia
- cGMP compliance
- Knowledge of lean six sigma or similar SPC, EPC
- Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem-solving techniques
- Ability to understand engineering processes through a logical, data driven, hands on approach
- Use of FMEA, FMECA and Risk assessment techniques
- Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective
- Strong report writing skills
- Experience of CAD systems, Gantt planning and Budgeting skills
Behaviours
- Focus on people and process.
- Motivating others positively
- Ability to work independently and in teams
- Natural influencer
- Be driven by task / project and will show flexibility to ensure results are best achieved.
- Self-starter and accustomed to setting personal goals
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
