Validation Engineering Specialist

Croda; Alabaster (AL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

Generous PTO

401K match

Wellness reimbursement

Career development

Life and AD&D insurance

Disability coverage

Paid holidays

Job summary

Croda is seeking a Validation Engineering Specialist for the Alabaster site. You will oversee the Site Validation Master Plan, coordinate plant, control, and computer system validations, and support process and cleaning validations to maintain cGMP compliance.

You will engage with internal and external stakeholders, drive lifecycle management for continued compliance, and assist Head of Quality in validation matters. Strong communication and regulatory submission support are essential.

Qualifications

• 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.
• SAP experience preferred; but not required.
• Database use and experience.

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.
• 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.

Skills

Validation experience

cGMP knowledge

ICH/FDA guidelines

GAMP5

ISPE guidelines

SAP experience

Database use

Education

Degree in relevant scientific discipline

Tools

SAP

Database software

Job description

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.

Who We’re Looking 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.

What You’ll Be 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

• Excellent Medical, Dental, and Vision coverage, available immediately.
• Generous PTO
• 401K Match
• Wellness ReimbursementParental Leave
• Career Development
• Company paid and voluntary Life and AD&D Insurance
• Short- and long-term disability
• Paid Holidays

Additional Information

This is a site-based role located in Alabaster, AL.

If you require any reasonable adjustments during the hiring process or experience any issues with our online application process, please email [e-mail].

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 are linked to 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, race, color, religion, national origin, gender, sexual orientation, gender identity, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable 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/Veterans. This Organization Participates in E-Verify.