QA Validation Engineer

PE Global (UK); Sligo; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading biotech company is looking for a Senior Project / Equipment Engineer in Sligo, Ireland. This role involves project management for manufacturing processes and requires a Bachelor's degree in Engineering with 3+ years of experience, ideally in biotechnology. Key responsibilities include scoping and executing technical projects, collaborating with multidisciplinary teams, and ensuring compliance with Good Manufacturing Practices. Interested candidates should submit their CV to apply.

Qualifications

• Experience in a biotech or aseptic pharmaceutical environment is preferred.
• Proven ability to deliver technical solutions and implement improvements.
• Experience in a GDP Compliant environment required.

Responsibilities

• Manage and execute assigned projects including prioritization and resource management.
• Work with stakeholders to ensure project requirements are satisfied.
• Coordinate the introduction of new processes and equipment.
• Develop and implement maintenance programs for new equipment.

Skills

Project management

Mechanical aptitude

Technical report writing

Collaborative work

Problem solving

Communication skills

Education

Bachelor's Degree in Engineering (Mechanical, Electrical or Chemical)

3+ years engineering experience

Tools

MS Office

MS Project

Job description

Overview

PE Global is currently recruiting for a Senior Project / Equipment Engineer on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

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

Role 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

Skills required

• 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,
• 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.
• Technical report writing and communication/presentation skills

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to [e-mail]

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