Job Title: Qualification & Validation SpecialistAbout the JobThe Quality & Validation (Q&V) department is the Quality Unit that reviews and approves validation lifecycle documents, procedures, and technical reports related to (1) facilities, equipment, utilities, (2) cleaning, (3) processes, (4) analytical methods, (5) requalification, (6) sterilization, (7) transport, and (8) computer systems. Q&V provides leadership, direction, and oversight for the MA BioCampus validation program and is responsible for ensuring inspection readiness in alignment with regulatory compliance requirements, current industry standards, and global Sanofi procedures.
Main Responsibilities- Quality oversight of qualification and validation tasks in his/her area
- Preparing and reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre-defined timelines.
- Ensuring proper documentation of deviations, non-conformances, and corrective actions
- Ensuring proper evaluation (validation expertise) of change controls
- Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards
- Participating in internal and external audits and inspections, providing necessary documentation and support
- Cooperating with cross-functional teams, including engineering, manufacturing, and quality control, to ensure smooth execution of validation activities
- Providing qualification and validation expertise when requested
- Identifying opportunities for improving qualification and validation processes and contributing to continuous improvement initiatives.
About YouBasic Qualifications- Bachelor's degree in science, engineering, technical field or any field with 9+ years of experience working in a regulated GxP environment
- OR Master's degree with 6+ years of experience working in a regulated GxP environment.
Preferred Qualifications- Proficiency in preparing and reviewing qualification and validation documentation, including protocols, reports, and standard operating procedures (SOPs)
- Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA) related to validation and qualification
- Ability to manage multiple validation projects simultaneously, ensuring they are completed on time and within budget
- Expertise in conducting risk assessments, analyzing validation data, and resolving deviations and non-conformances
- Excellent communication skills to effectively collaborate with cross-functional teams and train staff on validation procedures and best practices
The salary range for this position is:
$113,250.00 - $163,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
