Looking for a Validation Engineer to lead installation and all qualification activities (IOPQ) for Purified Water (PW) Systems and Clean-In-Place (CIP) / Cleaning equipment
Roles & Responsibilities
Minimum Qualifications
STRONG TECHNICAL EXPERTISE IN ALL ASPECTS OF QUALIFYING PURIFIED WATER SYSTEMS, CLEAN-IN-PLACE, AND EQUIPMENT CLEANING SYSTEMS AND PROCESSES
STRONG TECHNICAL EXPERIENCE WITH QUALIFICATIONS IN CLEANING AND VALIDATION.
STRONG TECHNICAL EXPERIENCE OF TCU (TEMPERATURE CONTROL UNITS)
• Direct hands-on experience with validation of process, cleaning, equipment, computer software, or facilities.
Working knowledge of processes in purification and/or formulation required
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
• Technical expertise in biotech unit operations, ability to handle multiple projects at one time
Strong leadership, organizational planning, and project management skills
• Excellent interpersonal effectiveness and communication skills (written and oral)
• Ability to work with a cross-functional team to achieve expected results
• Expertise in leading validation activities for labeling and HF RFID systems is helpful as well as label ribbon/ink label validation activities
Proficient in MS Word, Excel, and Project
OCCUPATIONAL DEMANDS:
Ability to lift 20-30 lbs. and stand for an extended period of time.
Bachelor's Degree in Engineering or Science discipline, an advanced degree is a plus.
4 years of relevant validation experience can be substituted in lieu of a Bachelor's Degree
YEARS OF EXPERIENCE:
Minimum 5+ years of relevant validation experience in a regulated industry with a Bachelor's Degree in Engineering or Science discipline; or
High School Diploma with 9+ years of relevant validation experience
Required Skills
PROCESS VALIDATIONFermentationpurificationvalidation protocolscomputer validation protocolsequipment validation
Work Authorization
Certifications & Clearance Requirements
Not Required
Benefits