Validation Engineering Specialist

Croda International•Alabaster, AL

4d•Onsite

About The Position

Croda is a FTSE 100 organisation where we truly believe our people are our difference and this, along with our values of Innovative, Responsible and Together, creates ‘our Purpose, Smart science to improve lives™’. With over 5,000 employees globally, we specialise in the research and development of innovative ingredients for the Life Science and Consumer Care markets. We are focused on developing our inclusive culture through accountability, collaboration, and innovation. By joining Croda, you will be part of a team who are using smart science to create a more sustainable future. As we deliver our ambitious 2030 Growth Strategy, we’re looking for a Validation Engineering Specialist, to undertake works in support of the site cGMP validation program to maintain compliance to ICHQ7. This individual will be responsible for oversight, coordination, and implementation of the site Validation Master Plan. Liaising with internal and external stakeholders to ensure a compliant validated state is maintained. Specific efforts will include the generation, completion, approval and archiving of all relevant validation documentation. The individual will also be the primary support for site validation activities.

Requirements

Degree in relevant scientific discipline or equivalent experience.
Knowledge of cGMP, ICH and FDA 210 + 211 guidelines.
Knowledge and experience of GAMP5.
Knowledge and experience of ISPE guidelines.
5+ years validation experience in a pharma environment.
Strong working knowledge of validation landscape.
Database use and experience.
Oral & written proficiency in the English language, internally with all functions on site, externally with suppliers, auditors and customers.
Proficient in MS Office.
Knowledge of electronic QMS systems.
Project Management skills.
Problem solving skills.
Efficient, reliable and competent in self-organization skills.
Able to work as a team.

Nice To Haves

SAP experience preferred; but not required.

Responsibilities

Coordinate implementation of the Site Validation Master Plan for plant, control systems and computer systems validation to support manufacture on site.
Responsibility for the Process Validation program for the site.
Responsibility for the Cleaning Validation program for the site.
Support of Laboratory and Analytical Method validation programs.
Plan, organize and coordinate multiple validation projects on site, both short and long term that will involve coordination with several internal and external stakeholders.
Develop and oversee lifecycle management processes for the demonstration of continued compliance.
Support and deputize for the Head of Quality in matters relating to validation.
Coordinate activities with site departments for the purpose of generating data for site regulatory submissions.
Assist with regulators and external customers as required in activities such as site inspections to relay information with regards to validation.
Manage the knowledge flow of validation information to customers in compliance with commercial contracts.
Assistance in generation of Annual Product Quality Reviews.
Prepare annual product quality review reports for site products.
Write/update and review standard operating procedures.
Additional Quality Assurance functions as required.