Katalyst CRO
Quality Equipment Qualification Engineer
We are seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols (IQ/OQ/PQ), preparing documentation, and ensuring equipment is fit for intended use in a pharmaceutical quality control environment.
Key Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and appropriate qualification.
Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation.
Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines.
Education & Experience
Bachelor's degree in Engineering, Life Sciences, or related field.
Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment.
Good understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment.
Proficient in writing and reviewing technical documentation.
Excellent organizational and communication skills.
Experience with computer system validation (CSV) and data integrity principles.
Ability to work independently and manage multiple priorities.
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Key Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and appropriate qualification.
Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation.
Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines.
Education & Experience
Bachelor's degree in Engineering, Life Sciences, or related field.
Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment.
Good understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment.
Proficient in writing and reviewing technical documentation.
Excellent organizational and communication skills.
Experience with computer system validation (CSV) and data integrity principles.
Ability to work independently and manage multiple priorities.
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