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Project engineer

Recruitment by Aphex
Project engineer
€80,000 - €100,000 a year
Posted: 22h ago
Offer description

Purpose

The Project / Equipment Engineer reports to the Senior Manager for Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and Inspection. This includes qualification of new equipment and implementation of associated reliability and maintenance programs.

Responsibilities

• Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.

• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation

• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up

• Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.

• Ability to translate strategic/emerging technology solutions into pragmatic executable plans

• Development and management of change controls

• Participate as a member of multidisciplinary site and multisite teams

• Development of detailed specifications, engineering documents, protocols and standard operating procedures

• Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.

• Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.

• Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures

• Support a safe working environment by complying with environmental health/safety practice, rules and regulations

• Travel may be required to support execution of projects

Qualifications

Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience

• Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes.

• Proven project management experience.

• Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous

• Demonstrated experience in a GDP Compliant environment.

• Experience in MS Office, MS Project, Change Control & Document Management Systems

• Proven ability working cross functionally, delivering technical solutions and implementing improvements.

• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results

• Technical report writing and communication/presentation skills

• Data driven decision maker

• Ability to work to tight deadlines in a fast-moving environment

Working arrangements

Requirement to be on site is greater than 50%. The onsite requirements can range from 3 to 4 days per week.

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