Job Description

Electronic Systems Validation Specialist - Pharma (Hybrid- Summit, NJ)

We are seeking a Learning Systems & Compliance Specialist- Pharma for a global pharmaceutical client. This position focuses on the creation and execution of computer system validation documents as well as providing operational support and guidance related to system use and improvement.

This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite role in Summit, NJ.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities:

• Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
• Provide electronic systems operational support and troubleshooting to end user.
• Own project, CAPA, and deviation/investigation-related tasks and/ or continuous improvement efforts.
• Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop a business case.
• Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives.
• Anticipate and perform troubleshooting and problem solving independently.
• Train and mentor others on electronic systems use and operation.
• Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution.
• Facilitate design, testing, and subsequent deployment of solutions. Support health agency inspection as equipment area subject matter expert.

Requirements:

• 6+ years of experience in LIMS, ELN, and laboratory data analysis systems preferably in a regulated environment.
• Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
• Knowledge of analytical and microbiological test methods and environmental monitoring programs is preferred.
• Demonstrated experience with validation and/or maintenance of laboratory information systems.
• Demonstrated technical writing skills. Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.

Please submit your resume to our network at (please apply to the Electronic Systems Validation Specialist - Pharma (Hybrid- Summit, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $60hr. - $66.65hr.

#LI-SW1

Job Tags

Similar Jobs