The Company
A global life sciences organization operating in regulated manufacturing environments, focused on delivering high quality pharmaceutical and healthcare products. The company works to strict GMP standards and supports complex engineering and validation projects across manufacturing sites.
About the Role
The Commissioning Qualification Engineer supports engineering and technical projects within a GMP environment. The role focuses on hands on commissioning, qualification and validation activities for secondary packaging systems. You will work closely with engineering and project teams to ensure systems meet regulatory and internal quality requirements.
Responsibilities
- Develop and update validation documentation including criticality assessments, validation plans, risk assessments, test protocols and summary reports
- Lead commissioning, qualification and validation activities for packaging systems
- Support system level testing and execution in line with approved validation strategies
- Provide technical guidance to project teams to ensure solutions align with validation plans and internal procedures
- Ensure compliance with GMP practices, policies and procedures
- Support reporting activities and maintain clear documentation throughout project phases
- Perform additional tasks as assigned by the supervisor
Requirements
- Engineering degree or related technical qualification
- Minimum 3 years experience in commissioning, qualification and validation within regulated manufacturing environments
- Hands on experience with secondary packaging systems
- Experience with print and inspection systems such as Systech and Cognex
- Experience in computerized systems validation
- Strong understanding of GMP compliance and documentation practices
- Ability to understand how individual documents fit within the overall validation lifecycle
- Good English technical writing and communication skills
Other Information
- Open to pharmaceutical or medical device industry backgrounds
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.