GxP Laboratory Systems Specialist (A-M)

In by

  • Location: Worcester, MA
  • Type: Contract
  • Job #15739

The recruitment team at Myticas Consulting is looking for an experienced GxP Laboratory Systems Specialist who would be interested in a contract opportunity offered within the Worcester, Massachusetts region.

Top 3-5 Requirements:

  1. Experienced integration Lab IT systems in a GxP Pharma environment
  2. Experience with Waters NuGenesis , Empower
  3. Experience integrating lab systems with Smartline Data Cockpit, OSI PI
  4. Executing projects and supporting users and systems
  5. Validating Lab IT systems

Nice to have:

  • Advanced degree, experience with OPC

Qualifications:

  • Candidate must have 5+ years of Life Sciences/GxP experience and prefer 3+ years of of Waters application knowledge (i.e. NuGenesis SDMS, Empower, Vision Publisher ELN) from an Information Technology perspective.
  • Experience in integrating instruments, applications and peripherals in a GxP lab environment, with applications such as Smartline Data Cockpit, and OSIsoft PI.
  • Knowledgeable in lab instrument software and applications such as Cytiva Akta Unicorn, Agilent HPLC, OpenLAB ECM, ChemStation
  • Application knowledge should include system administration experience and implementation of new software releases.
  • Candidate needs to be able to develop application solutions, and/or author and execute validation plans.
  • Experience in validating manufacturing systems in GMP Environment.
  • Good understanding of operating systems, networking components, data integrity, data security and database structures.
  • Works effectively with team/group to accomplish organizational goals.

Education:

  • Bachelor’s degree preferred in a relevant discipline; 5+ years of related experience.

Accountabilities:

  • The individual works under the direction of subject matter experts within Digital Systems.
  • Determines business objectives of assignments and contributes to the design of systems, programs, and processes; completes project tasks within time and budget constraints.

Scope of Work:

  • Provide system and validation support for projects and ongoing activities supporting Digital Systems – Lab Systems.
  • Author test plans and test scripts and execute them against requirements.
  • Author and maintain Risk Traceability Matrix.
  • Author and administer updates to standard operating procedures.
  • Provide system administration to the lab applications.
  • Provide analysis and problem solving – Applies analytical thinking skills to diagnose and make recommendations on system issues.
  • Provides end user support for lab applications and systems (tier 1 and 2). Works with corporate and vendor support teams to drive issues to resolution.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!