Galway based, exciting opportunity to join a dynamic team within the Engineering and Maintenance function, contributing to impactful projects in the pharmaceutical industry. My client is seeking individuals dedicated to supporting the vision of becoming a valued global provider of high-quality, competitively priced pharmaceutical products, with a commitment to excellence in services and customer support.
Reporting to the Director of Engineering, the Project Engineer will utilize strong fundamental engineering expertise to support the design, commissioning, and qualification of pharmaceutical equipment and building utilities on their site. Effective project management is crucial to ensuring compliance with GMP and regulatory requirements.
Key Responsibilities:
- Manage engineering and capital projects, ensuring compliance with GMP standards.
- Prepare user requirement specifications for various machinery/equipment and review vendor designs/specifications.
- Develop and execute FAT/SAT and commissioning qualification plans.
- Manage projects to agreed timelines and costs, including capital facility and equipment alterations and additions.
- Ensure project compliance with environmental, health, and safety standards.
- Maintain compliance with documented procedures and cGMP requirements at the highest possible standards.
- Achieve KPIs as outlined in the Performance and Development Plan.
- Lead project assignments and supervise outside contractors in compliance with company guidelines.
Competencies:
- Strong organizational skills, personal efficiency, time management, and the ability to prioritize competing demands.
- Self-starter with demonstrated efficient work methods, analytical and problem-solving skills, and the ability to handle multiple tasks.
- Relationship-building and collaboration skills are vital.
- Demonstrate and lead on the values, initiatives, and culture of an organization.
- Professional expertise.
Qualifications:
- BS in Engineering or another technical discipline.
- Minimum of 3 years of engineering experience.
- Experience in a cGMP Manufacturing and/or Biotechnology, pharmaceutical, or medical device company is desirable.
- Ability to work independently and as part of a team.
- Demonstrated initiative and self-starter.
- Experience using AutoCAD software package is also desirable.