Position Overview:
We are seeking a Lab PC Engineer to join our Lab IT Services team supporting pharmaceutical laboratory operations. The ideal candidate will have hands-on experience in deploying IT solutions in regulated GxP environments and will be responsible for ensuring compliance with industry standards including FDA 21 CFR Part 11, EU Annex 11, and GAMP guidelines.
Key Responsibilities:
Technical Responsibilities:
* Gather, analyze, and contribute to Lab PC system requirements.
* Design and implement system solutions aligned with pharmaceutical and regulatory standards.
* Install and configure laboratory software applications according to specifications.
* Manage operating system upgrades and platform migrations.
* Author and contribute to documentation such as user requirements, functional specifications, configuration documents, and technical requirements.
* Develop and update Standard Operating Procedures (SOPs).
* Assist with system testing, script execution, and authoring change requests (CRs).
* Manage Lab PC hardware assets, adhering to laboratory best practices and inventory control procedures.
* Build, image, deploy, and decommission Lab PC systems.
* Respond to incidents and fulfill service requests using IT service management systems; escalate and resolve issues passed on from Level 1 support teams.
Compliance Responsibilities:
* Adhere to procedures for periodic reviews and data integrity in GxP environments.
* Conduct security and audit trail reviews to assess data generation, modification, deletion, and metadata changes in Lab PC and software systems.
* Identify remediation needs and follow up on corrective actions post-review.
* Apply Windows 10 security patches, perform system reboots, and verify system functionality per SOPs.
Managed Service & Stakeholder Engagement:
* Provide a monthly one-page summary report covering training, operational activities, projects, and meeting schedules.
* Participate in monthly performance check-ins with the service manager.
* Work on-site or in a hybrid capacity based on business requirements.
* Maintain a professional and collaborative relationship with internal teams and stakeholders, demonstrating strong customer service orientation.
Experience Required:
* 2–3 years of experience in a pharmaceutical QC laboratory environment.
* 3–5 years of experience installing, configuring, and troubleshooting hardware, operating systems, applications, and networks in both GxP and non-GxP settings.
Educational Qualifications:
* Bachelor’s degree in Computer Science or related field (or equivalent experience).
* Preferred: Recent certifications such as Microsoft (MCSA/MCSE), CompTIA (A+/Network+/Security+), or ITIL Foundation.
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