Overview
On Site
Full Time
Skills
Regulatory Compliance
Editing
Collaboration
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 Description:
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.
The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validation strategies that enable compliant and efficient operations in an early-phase clinical environment.
Roles & Responsibilities:
Independently understanding quality standards, cGMP's, and regulatory standards to support team in compliance of validation effort.
Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software.
Actively consult clients on regulatory validation processes and standard industry acceptable practices.
Collaborate with cross-functional teams including Manufacturing, Facilities, Quality Control nd Quality Assurance to ensure validation activities are properly scoped and executed.
Ability to take 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 ctivities. Includes 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 nd standards.
Excellent documentation, analytical, and problem-solving skills.
Ability to work independently and as part of a team
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.
The Senior Validation Engineer will act as a subject matter expert, collaborating closely with cross-functional teams, including Manufacturing, Facilities, Quality Control and Quality Assurance to deliver robust validation strategies that enable compliant and efficient operations in an early-phase clinical environment.
Roles & Responsibilities:
Independently understanding quality standards, cGMP's, and regulatory standards to support team in compliance of validation effort.
Authoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software.
Actively consult clients on regulatory validation processes and standard industry acceptable practices.
Collaborate with cross-functional teams including Manufacturing, Facilities, Quality Control nd Quality Assurance to ensure validation activities are properly scoped and executed.
Ability to take 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 ctivities. Includes 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 nd standards.
Excellent documentation, analytical, and problem-solving skills.
Ability 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.