Quality Engineer

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

Position: Quality Engineer

Job Description:

We are currently expanding our team and are looking for a quality engineer on site with a client. In summary, you will be supporting commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

Key Responsibilities:

• Provide QA oversight across the equipment and process validation lifecycle, including commissioning, qualification, performance qualification, and process validation activities.
• Review and, where applicable, approve validation deliverables
• Review executed qualification and validation documentation for completeness, accuracy, data integrity, traceability, and compliance with approved procedures and GMP requirements.
• Support qualification activities for manufacturing and process equipment, such as bioreactors, vessels, skids, filtration systems, filling or dispensing equipment, and other upstream or downstream process systems, depending on project scope.
• Assess validation deviations, discrepancies, exceptions, and test failures, ensuring that appropriate investigations and corrective actions are documented and completed.
• Work closely with Validation, Engineering, Manufacturing, Automation, Quality, and equipment vendors to resolve technical and compliance-related issues.
• Where applicable, support MES activities, including test execution, manufacturing recipe creation or configuration, recipe verification, and associated validation documentation.

Requirements:

• Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). ·
• Min. 5 years of relevant experience in deviation investigations within GMP environments (pharma, biotech, manufacturing).
• Excellent communication skills, both written and verbal, in English.
• Ability to multitask and work in a fast paced environment with competing priorities.
• Great team player. Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels

What’s In It for You?

• Exposure to the major Pharmaceutical Companies in the industry.
• Annual leave benefits.
• Full Health coverage and benefits.
• Training and Development allowance.

What's Next?

If you are interested in applying for this position, please send an email to [email protected].

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.