Validation Specialist
Validation Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Summary:
The Validation Specialist will support process validation activities for a technology transfer project in a pharmaceutical manufacturing environment. This role involves developing technical documentation for change control and process validation as well as performing sampling and handling in compliance with regulatory standards.
Key Responsibilities:
- Develop and execute process validation protocols (IQ OQ PQ) for technology transfer projects.
- Prepare and maintain technical documentation for change control validation reports and regulatory submissions.
- Conduct sampling activities in assigned areas ensuring proper handling and documentation in a regulated environment.
- Collaborate with manufacturing quality assurance regulatory and engineering teams to ensure validation compliance.
- Analyze validation data identify trends and recommend improvements to optimize manufacturing processes.
- Ensure compliance with GMP FDA and industry regulations related to validation activities.
- Support audits and inspections by providing validation documentation and technical expertise.
- Assist in troubleshooting and resolving validation-related issues during technology transfer.
Qualifications & Experience:
- Bachelors degree in Engineering Life Sciences or a related field.
- 3-5 years of experience in process validation within a pharmaceutical or regulated manufacturing environment.
- Strong understanding of GMP FDA and ISO regulations related to validation and technology transfer.
- Experience in change control documentation and validation lifecycle management.
- Hands-on experience with sampling techniques and regulatory handling procedures.
- Excellent analytical problem-solving and technical writing skills.
- Ability to work independently and collaboratively in a cross-functional team.
Preferred Skills:
- Knowledge of statistical analysis tools for validation data interpretation.
- Ability to operate specialized laboratory equipment and computers as appropriate.
- Ability to interpret and apply GLPs and GMPs.
- Familiarity with risk assessment methodologies in validation processes.
Work Methodology:
- Professional services contract
- 6-12 months of project assignment with potential extension
- Administrative shift Monday to Friday 8am - 5pm with availability to support activities in non-standard hours
- On-site job
Required Experience:
Unclear Seniority
Employment Type
Full Time
