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:
- Experienced integration Lab IT systems in a GxP Pharma environment
- Experience with Waters NuGenesis , Empower
- Experience integrating lab systems with Smartline Data Cockpit, OSI PI
- Executing projects and supporting users and systems
- 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.