Validation Engineering Specialist

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:

The successful candidate will receive a competitive salary and benefits package including:
• Excellent Medical, Dental, and Vision coverage, available immediately.
• Generous PTO
• 401K Match
• Wellness Reimbursement
• Parental 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 [email protected].