Quality , Science, Pharmaceutical & Food
Instrumentation Maintenance Specialist
- Swords, County Dublin, Ireland
PE Global is currently recruiting a QC Instrumentation Maintenance Specialist for a 12 month contract, with a leading multi-national client based in Swords.
This is initially a 11 month contract position.
The role of Quality Control (QC) Maintenance Instrumentation Systems Specialist in Dublin operates as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab.
The team working style is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation.
Our Quality Control group ensures all materials used for our products is manufactured, processed, tested, stored, and distributed aligned with our incredibly high standards of quality, meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Duties of the role/Responsibilities
- The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:
- Responsible for the maintenance of the QC systems and instrumentation, in compliance with up-to-date data integrity, regulatory, and industry standards
- Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
- Support the QC department for troubleshooting, investigations, and deviations as an SME.
- Manage deviations, CAPA’s and change control’s related to QC systems and instrumentation and team priorities.
- Author and revise local SOPs, work instructions, and guidelines.
- Serve as an SME for regulatory and internal inspections and audits.
- Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop.
- A bachelor’s degree in Engineering, biological science, or related field.
- Typical Minimum Experience:
- 3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation
- Experience in regulatory audits.
Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP)
- Strong CSV experience with analytical instrument maintenance
- Excellent understanding of data integrity compliance requirements
- Demonstrated ability to drive complex tasks to completion.
- Strong organizational, problem-solving, and continuous improvement skills
- Ability to prioritize activities in line with the maintenance schedules and business needs.
- Ability to maintain the flexibility to react to changing business needs.
- Experience and understanding of the change management requirements of validated systems and software.
- Excellent communication skills both verbal and written.
- Ability to handle multiple projects and deliver on critical deadlines.
- Demonstrated ability to work independently on own initiative and manage time.
- Demonstrate ability to work with a team and co-ordinate work to meet a common goal.
- A high level of self-motivation, knowledge, enthusiasm, and drive.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up to date CV to firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***