Pharmaceutical & Biotechnology

Laboratory Systems Specialist

Posted 2 weeks ago
Contract
North Dublin, County Dublin, Ireland
42055488

PE Global is recruiting for a Laboratory Systems Specialist on behalf of our biopharmaceutical client in Dublin. This is an initial 12-month contract hybrid role.

Role Description

The Quality Control (QC) Systems Specialist supports the QC Laboratory through routine maintenance, troubleshooting and repairs of all analytical laboratory instruments, in addition to supporting the instrument lifecycle as a whole (installation, qualification, operation, and retirement).

The QC Systems Specialist leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise.

The QC Lab System team ensures that QC objectives are effectively achieved and consistent to ensure compliance, safety, and reliable supply to our customers.

Role Functions

The QC Maintenance 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.

Experience, Knowledge & Skills

Technical:

Strong experience with analytical instrument maintenance, CSV experience beneficial.
Excellent understanding of data integrity compliance requirements.
Demonstrated ability to drive complex tasks to completion.
Strong organizational, problem-solving, and continuous improvement skills.

Business:

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

Leadership:

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 coordinate work to meet a common goal.
A high level of self-motivation, knowledge, enthusiasm, and drive.

Qualifications