
Pharmaceutical Equipment Specialist
6 days ago
Equipment Qualification Specialist
Job Overview:
We are seeking a skilled professional to support our pharmaceutical manufacturing operations. The ideal candidate will have a passion for ensuring quality and compliance in equipment qualification, process validation, and site requalification programs.
Key Responsibilities:
- Develop and execute Process Performance Qualifications (PPQ).
- Conduct validation studies for equipment, systems, and processes.
- Evaluate all validation activities against regulatory requirements and industry standards.
- Provide technical interpretation and guidance on FDA and EU validation guidelines.
- Maintain comprehensive validation documentation throughout the lifecycle.
Requirements:
- 3-5 years' experience in a healthcare manufacturing environment.
- Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical).
- Strong technical knowledge of pharmaceutical plants, validation, and process development.
- Familiarity with cGMP, GAMP, ISPE, FDA/EU guidelines, and validation standards.
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