Pharma Validation Engineer — cGMP Compliance Lead

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 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.