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PharmEng Nordic ApS

LIMS Support Specialist

PharmEng Nordic ApS, Swiftwater, Pennsylvania, United States

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LIMS Support Specialist Quality Control (QC) Onsite | Swiftwater, PA Consulting or Full-Time Opportunity

We are seeking a

LIMS Support Specialist

to provide hands‑on support to the

Quality Control (QC)

department. This role involves LIMS configuration, master data governance, and project support activities aligned with GMP and regulatory requirements.

Key Responsibilities LIMS Configuration & Technical Support

Customize and configure the LIMS platform to align with lab workflows, testing needs, and terminology.

Modify standard software code or develop new code to meet unique lab requirements.

Ensure user workflows, reports, and data elements are integrated without altering base code.

Serve as the

LIMS System Owner , managing system changes and upgrades.

Data Governance & Compliance

Build and support a master data governance model for vaccine product specifications and analytical testing.

Ensure alignment with cGMP and data integrity requirements across QC instruments and systems.

Manage and maintain master specification documents for commercial products.

Oversee static master data for QC‑LIMS, ensuring data accuracy, ownership, and semantic consistency.

Support audit readiness, regulatory inspections, and compliance‑driven documentation.

Cross‑Functional Collaboration

Work closely with internal QC teams, IT development teams, and global stakeholders.

Support the Data Logistics & Support (DLS) Department in meeting operational and project milestones.

Lead and contribute to LIMS master data management efforts for analytical testing portfolios.

Qualifications Experience supporting or configuring

LIMS platforms

(LabWare, STARLIMS, or similar) in a GMP‑regulated environment.

Familiarity with

QC laboratory workflows , analytical testing, and regulatory compliance.

Strong understanding of

master data governance

and scientific data semantics.

Proficient in

LIMS system ownership , change control processes, and cross‑department coordination.

Excellent documentation, communication, and stakeholder engagement skills.

Note : Applicants must be

eligible to work in the U.S.

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