MV01-080725 Sr Validation Specialist (IN)
MV01-080725 Sr Validation Specialist (IN)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Validation & Engineering Group Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:
- Senior Validation Engineer
Job Summary:
Hands on CQV/validation work supporting device assembly and automation projects for a combination autoinjector product. Ideal candidates will bring a strong cGMP background and experience with automated systems packaging and FMEAs.
Key Responsibilities:
- Lead or support CQV activities for equipment utilities and processes in accordance with cGMP and client procedures (including IQ/OQ/PQ).
- Oversee design and process FMEA development and execution.
- Support assembly packaging and automation equipment qualification related to autoinjector devices.
- Participate in vendor reviews FATs/SATs and tech transfers (including international travel).
- Collaborate with cross-functional teams including engineering quality automation and project management.
- Ensure compliance with applicable regulatory and quality standards (FDA EMA ISOCFR Part 4).
- Review and approve technical documentation such as validation protocols reports and risk assessments.
- Interface with stakeholders to support project planning scheduling and execution.
Qualifications:
- Bachelors degree in Engineering Life Sciences or related field.
- 5 years of experience in CQV validation or technical operations within regulated environments.
- Strong knowledge of cGMPs validation lifecycle and regulatory expectations.
- Proven experience with combination products preferably autoinjector platforms.
- Hands-on experience with automated device assembly equipment vision systems and packaging machinery.
- Experience with DFMEA/PFMEA methodologies.
- Willingness to travel internationally for vendor engagements.
- Excellent written and verbal communication skills.
Required Experience:
Senior IC
Employment Type
Full Time
