Validation Engineering Specialist

Validation Engineering Specialist

Croda is a FTSE 100 organisation where wetruly believeour 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 5000 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 accountabilitycollaborationand 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 Strategywerelooking for a Validation Engineering Specialist t o 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.

WhoWereLooking For:

Degree in relevant scientific discipline or equivalent experience.

Knowledge and 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.

SAP experience preferred; but not required.

Database use and experience.

WhatYoullBe Doing:

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.

Requires a persuasive tenacious personality who can transfer verbal discussion into written communication through site validation documentation and procedures ensuring the ensuing systems are implemented and maintained to a high standard and in compliance with quality and validation requirements.

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.

COMMUNICATION SKILLS
Must have oral & written proficiency in the English language internally with all functions on site externally with suppliers auditors and customers.

COMPUTER SKILLS
Proficient in MS Office.
Knowledge of electronic QMS systems.

OTHER SKILLS
Project Management skills.
Problem solving skills.
Efficient reliable and competent in self-organization skills.
Able to work as a team.

Physical Demands
Able to walk sit or stand for a minimum of 8 hours per day.

What We Offer:

The successful candidate will receive a competitive salary and benefits package including:

Excellent Medical Dental and Vision coverage availableimmediately.

Generous PTO

401K Match

Wellness Reimbursement

Parental Leave

Career Development

Company paid and voluntary Life and AD&D Insurance

Short- and long-termdisability

Paid Holidays

Additional Information:

This is a site-based rolelocatedin Alabaster AL.

If yourequireany reasonable adjustments during the hiring process or experience any issues with our online application process please email

Why Croda

At Croda we believe our people are our difference. We are people-led driven by the desire to do good and deliver value a unifying principle shaped by all the great people that have travelled through Croda since our beginning in 1925. We pride ourselves on bringing together diverse teams and talents from across the globe and guided by our values of Responsible Innovative and Together we are passionate about building an inclusive collaborative and diverse organisation with innovation and customer focus underpinning all that we do.

Croda recognizes employees as our strength and the diversity they bring to our workforce arelinkedto our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate based on any protected attribute including age racecolor religion national origin gender sexual orientation gender identity gender expression marital or veteran status pregnancy or disability or any other basis protected under applicable accordance withapplicable law we make reasonable accommodations for applicants and employees religious practices and beliefs as well as any mental health or physical disability needs.

Equal Opportunity Employer/Disability/ Organization Participates in E-Verify.

Required Experience:

IC