What are the responsibilities and job description for the Process Engineer (Validation/Biotech/Pharma) position at Infotree Global Solutions?
Description:
Note:
Fully Onsite
Experience needed:
Cold Storage Validation Experience
Analytical Equipment experience
Preferably Lab Ops/Equipment Background
Drafting Documents
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
Basic Qualifications
Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience
Top Must Have Skill Sets:
-Strong and clear communication skills
-Paying attention to details
-Drafting documentation
-Nice to specifically have cold storage and computerized Analytical Equipment familiarity
-Ability to switch on different project at the same time
-Can work as a team player and independently
Day to Day Responsibilities:
This role is responsible for ensuring compliance with cold storage validations, computer validations for analytical laboratory instruments, and supporting ad hoc laboratory operations projects. Key duties include participating in system design, preparing and executing test protocols, analyzing results, and generating summary reports. The position provides guidance on IT compliance and quality documentation standards, serves as a liaison between laboratory, IS, and Quality functions, and ensures timely resolution of issues during installation and qualification activities. Success in this role requires strong communication and multitasking skills, the ability to follow established procedures, and the flexibility to work independently as well as within a team. Onsite presence is require