Validation Engineering Specialist

Croda Singapore; Alabaster, Northern (AL, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

Wellness Reimbursement

Parental Leave

Life Insurance

AD&D Insurance

Short-term Disability

Long-term Disability

Job summary

Croda is seeking a Validation Engineering Specialist to oversee the Site Validation Master Plan for plant, control, and computer systems at our Alabaster site. You will manage process and cleaning validation programs and support analytical method validation.

You will coordinate multiple validation projects, ensuring ongoing compliance, and act as a liaison with regulators and customers during inspections. Strong documentation and teamwork 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/ICH/FDA guidelines

GAMP5 knowledge

ISPE guidelines

SAP experience (preferred)

Data management

Education

Degree in relevant scientific discipline

Tools

SAP

Database use

Job description

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 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’relooking 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.

WhoWe’reLooking 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, availableimmediately.
• Wellness Reimbursement
• Parental Leave
• Company paid and voluntary Life and AD&D Insurance
• Short- and long-termdisability

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 [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 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, 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 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/Veterans.This Organization Participates in E-Verify.