Dunboyne, Ireland | Posted on 06/02/2025
* Industry: Pharma/Biotech/Clinical Research
* Work Experience: 4-5 years
* Location: Dunboyne, Meath, Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in over 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing professionals, and metrology services.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as a key differentiator, offering the opportunity to work with talented professionals in the Pharma/Biotech Industry. We provide permanent contracts, enabling exposure to top pharmaceutical client sites in diverse cultural settings.
Employee Value Proposition
We value our employees as the 'heartbeat' of PSC Biotech, offering empowering career development through in-house training, mentorship, and continuous guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations regarding quality, budget, and timelines.
Job Purpose
* This role is part of the Technical Operations Team within the Biologics R&D at our single-use multi-product biologics facility.
* The Laboratory Systems Lead will support the implementation and configuration of Laboratory Systems, working across the site and R&D to support the biologics pipeline.
* This role involves testing of incoming raw materials, in-process, drug substance/drug product, and stability samples, and building Lab IT Systems to support Tech Transfer/Commercialization.
Requirements
Key Responsibilities:
* Serve as SME on data management systems for laboratory instrument control, including LIMS, Waters Empower, LabX, Softmax Pro, and others.
* Build and support Lab IT Systems for biologics Tech Transfer/Commercialization and manufacturing.
* Monitor and ensure laboratory systems compliance with cGMP and SDLC standards, including change control and documentation.
* Implement industry best practices for Laboratory Systems processes supporting sample management, testing, and validation.
* Ensure compliance with evolving GMP requirements and trends.
* Train personnel on Laboratory System procedures.
* Participate proactively in process improvements, including change controls, documentation, CAPAs, and audit readiness.
* Continuously improve Laboratory Systems efficiency and compliance.
* Provide troubleshooting, technical guidance, and support for business needs.
* Promote a 'right first time' culture through lean principles, standard work, and visual management.
* Update site achievements and challenges collaboratively, working cross-functionally to resolve obstacles.
Educational and Experience Requirements:
* Degree in a technical discipline (Biochemistry, Chemistry, Engineering).
* Minimum 2 years’ experience with Laboratory Systems.
* Experience with configuring and maintaining laboratory management systems like LIMS, LabX, Empower, with scripting interest.
* Experience in GMP-regulated pharma/biopharma industries is desirable.
* Knowledge of analytical methods (HPLC, ELISA, PCR, etc.).
* Understanding of GMP, ICH, USP, and global regulations related to analytical development and validation.
* Excellent communication skills.
* Strong technical aptitude and ability to understand technical documents and procedures.
* Proven ability to work cross-functionally and manage priorities.
* Organizational skills to handle multiple priorities and escalate issues appropriately.
* Logical thinking and proactive under pressure.
* Ability to work independently and as part of a team.
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