Job Overview
We are seeking a highly skilled and experienced Validation Specialist to join our team. This individual will be responsible for ensuring the ongoing validation and compliance of equipment, systems, and processes within our facility.
Key Responsibilities:
* Designing, executing, and reporting on Process Performance Qualifications (PPQs) and other validation studies.
* Ensuring all validation activities are managed in accordance with relevant standards and regulations, including cGMP, Health & Safety, and environmental requirements.
* Providing technical guidance and interpretation of current FDA and EU validation requirements for aseptic processing, lyophilization, sterilization, and dehydrogenation.
* Maintaining accurate and up-to-date validation documentation throughout the validation lifecycle.
Required Skills and Qualifications:
To be successful in this role, you will need:
* A degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical, or Electrical).
* At least 3-5 years of experience working in a healthcare manufacturing environment, preferably in the pharmaceutical sector.
* Strong troubleshooting skills, with the ability to resolve validation issues associated with projects and process development.
* Excellent technical knowledge of pharmaceutical plants and processes.
* Prior experience in validation/product development would be highly advantageous.
* Familiarity with Process Validation regulations, industry practices, and guidelines, including GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO standards.
* Ability to execute projects efficiently and effectively.
* Good understanding of quality management systems and KPIs.
Benefits:
This role offers the opportunity to work with a dynamic team, contributing to the success of our organization. As a valued member of our team, you can expect:
* A competitive salary and benefits package.
* Ongoing training and professional development opportunities.
* A collaborative and supportive work environment.
How to Apply:
If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter outlining your qualifications and experience.