Position: CSV 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.
Job Description:
We are currently expanding our team and are looking for a CSV Engineer to support projects on site with a client.
In summary, you will be responsible for managing all computer systems validation activities including, but not limited to, drafting, reviewing, and approving all CSV-related activities, as well as conducting deviation investigations, and working alongside the teams that provide QA oversight to ensure consistent compliance of cGMP standards.
Key Responsibilities:
- Establish Cleaning Validation master plans and execution plans for GMP Equipment comprising of both API and Biologics manufacturing facilities.
- Collaborate with validation and tech support teams in other sites to ensure a consistent and cohesive approach to Cleaning Validations.
- Conduct deviation investigations, identification and completion of corrective and preventative actions.
- Supervise contractors, engineers and provide day to day support to operations including, modifications and changes to processes and equipment, and troubleshooting activities.
- Analyse business trends, and propose solutions to issues that can potentially impact the validation status of GMP equipment.
Requirements:
- Degree in Science or Engineering or any other related qualifications.
- Familiar with government code of practice, regulations, current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP).
- At least 3-8 years of experience in to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
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.
