Project Engineer

Desired Skills: Engineering Projects,Oral Solid Dosage,Equipment Engineering,Project Management,Drug Product Manufacturing,Change Controls,GMP

Responsibilities:

• To provide Engineering services to the plant, in order to maximise the availability of all Site Process Equipment and Utilities.
• To manage capital engineering projects within site following the company Project Lifecycle approach (typical project value range: anything up to €5 million).
• To support the engineering teams in controlling uptime of process equipment and optimizing efficiencies both in equipment and process performance.
• To support the Engineering team with the emphasis on continual operational improvements.
• To provide process engineering support and technical trouble shooting within the site.
• To improve the operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives.
• To manage the execution of projects within the engineering group including specific Process Safety Projects.
• To support the provision of process safety initiatives to the site.
• To liaise with Production to ensure equipment performance is maximized.
• To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment.
• To provide engineering support and technical trouble shooting to all site operations and reliability of equipment and processes by the successful identification and implementation of continuous improvement initiatives.
• Leadership of process equipment commissioning and validation activities.
• Identification and project management of continuous improvement projects.
• Work closely with all site functions and other departments to deliver these continuous improvement projects.
• Preparation of feasibility studies and budget management for all assigned projects.
• Management and negotiation of external contracts and contractors.
• Support all major site initiatives and sites core goals.

Requirements

ESSENTIAL

• Degree in a relevant Engineering Discipline (Mechanical/Chemical/Process)
• 5 years + strong site experience in API Manufacturing / OSD Manufacturing / BioPharm but will consider more junior (3 years) if they have relevant project site experience.
• Proven track record in delivering Capital Projects – new equipment, utilities, facilities, etc.
• Good knowledge of change control and C&Q processes/execution.

Must have demonstrated relevant site experience of one or more of the below:

• API process equipment trains (reactors, filter dryers, pumps, process pipework,
• milling, containment technology – gloveboxes, downflow booths, etc.).
• Drug Product equipment (tablet press, roller compaction, tablet coater, material
• handling – post hoists, blenders, milling – Quadro Comils, etc.)
• Cleanroom processing/utilities – HVAC, CIP systems, Purified water generation
• and distribution systems, etc.
• Knowledgeable/competent with executing change control.
• Experience in process engineering, with relevant experience of batch processing,
• automation, project management, commissioning and validation, equipment reliability
• and continuous improvement.
• Working knowledge of distributed control systems, such as Delta V.
• This is a hand-on role requiring a logical and structured approach to resolving day to
• day engineering issues typical of a live manufacturing environment.
• Knowledge of cGMP and regulatory requirements relating to the Healthcare industry is
• Demonstrated project management skills, including the ability to deliver projects on
• schedule, within budget, and meeting the predefined quality requirements.

DESIRABLE

• Trackwise change control system experience.
• Electrical background – competency with electrical system design & installation
• (process equipment and site electrical infrastructure), familiar with ATEX regulations
• and requirements.

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***