A speciality biopharmaceutical company that are focused on making high quality products for rare diseases are currently seeking a Cleaning Validation Lead.
The Cleaning Validation Lead will be responsible for providing cleaning validation oversight and owning the cleaning validation programme in relation to the manufacturing facility, utilities and process equipment.
Their goal is to become a top quartile specialty biopharmaceutical company within the next 5 years. This has resulted in expenditure of more than $7 bn in a series of role's.
Role: Cleaning Validation Lead
Location: Dublin West
Contract: 12 Month - Daily rate
Roles and Responsibilities:
- Leading the Cleaning Validation team ensuring effective performance of all team members
- Ensure industry best practices are incorporated into Cleaning Validation activities
- Act as Change Control assessor for changes in relation to cleaning validation
- Develop, own and project manage the Cleaning Validation approach and schedule in relation to cleaning validation
- Responsible for drafting, reviewing and approving Cleaning Validation documentation for facility and equipment.
- Assisting in determining project schedules and the relevance of appropriate levels of validation.
- Ensuring Data Integrity requirements are met.
- Ensure Cleaning validations against corporate SOP/FDA/EMEA requirements.
- Understanding and applying industry specific compliance standards/regulations to all Cleaning Validation activities.
Cleaning Validations and Education Requirements:
- Bachelor's Degree in engineering or scientific discipline preferred plus 5 -10 years' experience working as a Lead cleaning validation in a cGMP manufacturing environment
- Direct experience performing cleaning validation studies in a cGMP pharmaceutical environment is required.
- Must be able to analyze data using basic statistical methods.
- Good interpersonal skills are required, as is the ability to communicate well, both verbally and written. Must be able to function effectively in a teamwork environment
This is an excellent opportunity for an experienced Cleaning Validation engineer who is looking for a role in Dublin.
For immediate consideration please apply with an up to date CV. Not sure yet? No CV ready? Give me a call for more information
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales