Overview
On Site
Full Time
Skills
Startups
Editing
Manufacturing
Quality Control
Quality Assurance
Leadership
Management
Root Cause Analysis
Life Sciences
Pharmaceutics
Computerized System Validation
Good Manufacturing Practice
GAMP
Documentation
Analytical Skill
Problem Solving
Conflict Resolution
Job Details
Job Summary :
- The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment.
- This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements
- Roles & Responsibilities:
- uthoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software
- ctively consulting clients on regulatory validation processes and standard industry acceptable practices
- Collaborating with cross-functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed
- Taking independent leadership role on project(s)
- Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities- including ability to complete root cause analysis.
- Education & Experience :
- Bachelor's degree in engineering, Life Sciences, or a related field
- 5+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech)
- Experience with facility, utility, equipment, and computer system validation. Preferably in start-up of early-phase clinical biomanufacturing facilities
- Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., ISPE, GAMP)
- Experience working with start-up clients, without well established company procedures and standards
- Excellent documentation, analytical, and problem-solving skills
- bility to work independently and as part of a team
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.