Dunboyne, Ireland | Posted on 05/28/2025
* Industry: Pharma/Biotech/Clinical Research
* Work Experience: 4-5 years
* City: Dunboyne
* State/Province: Meath
* Country: 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 more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals 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 one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals in the Pharma/Biotech Industry. We offer a permanent employment contract providing exposure to top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech. We offer unparalleled 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, staying within budget, and meeting timelines.
Job Purpose
* This role is part of the Technical Operations Team within the Biologics AR&D at our single-use multi-product biologics facility.
* The Laboratory Systems Lead will work across the site and AR&D to drive proactive programs to support the pipeline delivery.
* This role involves supporting the implementation and configuration of Laboratory Systems, testing of raw materials, in-process, drug substance/drug product, and stability samples.
* The role includes building Lab IT Systems to support Tech Transfer/Commercialization of the biologics pipeline.
Requirements
Key Responsibilities:
* Serve as SME on data management systems for laboratory instrument control, including LIMS, Waters Empower, LabX, Softmax Pro, etc.
* Build and support Laboratory IT Systems for Tech Transfer/Commercialization and manufacturing of biologics, ensuring compliance with cGMP and SDLC standards.
* Implement industry best practices for Laboratory Systems processes related to sample management, testing, and validation.
* Ensure Laboratory Systems compliance with evolving GMP requirements.
* Provide training on Laboratory System procedures.
* Participate proactively in process improvements, change controls, documentation, CAPAs, and audit readiness.
* Continuously improve Laboratory Systems for efficiency and compliance.
* Support troubleshooting, technical guidance, and problem-solving.
* Promote a ‘right first time’ environment through lean principles.
* 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 systems like LIMS, LabX, Empower, with scripting interest.
* Experience in GMP regulated pharma/biopharma industry 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 read/write technical documents.
* Ability to work cross-functionally, manage priorities, and work proactively under pressure.
* Team player with initiative and organizational skills.
#J-18808-Ljbffr