Equipment Qualification Engineer
Job Summary
We are seeking a Qualification Engineer to support equipment qualification activities in a GMP-regulated manufacturing environment. The role involves executing IQ, OQ, and PQ activities, preparing and reviewing GMP qualification documents, and collaborating with cross-functional teams. You will ensure that all equipment readiness, risk assessments, and documentation align with strict GMP and data integrity standards.
Responsibilities
- Execute IQ, OQ, and PQ activities
- Prepare and review GMP qualification documentation
- Manage equipment risk assessments and deviation handling
- Collaborate with cross-functional engineering and quality teams
Required Skills
- 2-3 years of GMP equipment qualification experience
- Proficiency in IQ, OQ, PQ validation lifecycle
- Strong knowledge of GDP and data integrity principles
- Bachelors degree in Engineering or Life Sciences
Job Details
Responsibilities:
- Support qualification activities for manufacturing equipment used in GMP production.
- Execute and document IQ, OQ, and PQ activities.
- Prepare and review qualification protocols, test scripts, reports, and other GMP documents.
- Work closely with Engineering, Manufacturing, Quality, Validation, and Maintenance teams.
- Support equipment readiness checks, risk assessments, deviation handling, and qualification strategy discussions.
- Ensure all qualification work follows GMP, GDP, and data integrity requirements.
- Review and support approval of documents related to the equipment qualification and validation lifecycle.
Qualifications & Requirements:
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline.
- Minimum 2–3 years of experience in manufacturing equipment qualification within pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments.
- Hands-on experience with equipment qualification activities, including IQ, OQ, PQ, validation documentation, and qualification lifecycle management.
- Good understanding of GMP, GDP, deviation management, change control, and data integrity principles.
- Ability to independently review, execute, and manage qualification protocols and related documentation.
- Strong communication and stakeholder management skills, with the ability to collaborate across cross-functional teams.
- Experience in CQV projects, technology transfer, or new facility/equipment setup will be an added advantage.
- Exposure to biologics, sterile manufacturing, API, or vaccine manufacturing environments is preferred.
- Experience supporting audits, inspections, or regulatory readiness activities is an advantage.
- Fluent in English, both written and spoken.
Good to have:
- Experience with pharmaceutical or biotech processing equipment such as bioreactors, chromatography systems, ultrafiltration/filtration systems, hold tanks, vessels, or other GMP manufacturing equipment.