Engineer I, Process Validation

The Position

We are seeking a highly skilled and motivated Process Validation Engineer with a strong background in Good Manufacturing Practices (GMP) to join our team. This individual will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation. The ideal candidate will have a minimum of 8 years of experience in GMP validation or related fields, with at least 3 years of GMP manufacturing experience preferred.

Responsibilities

• Draft and review process validation and cleaning validation protocols and reports, ensuring compliance with GMP regulations.
• Oversee and manage the execution of manufacturing validation activities, ensuring timelines and quality standards are met.
• Collaborate with cross-functional teams to ensure validation strategies align with production requirements and regulatory guidelines.
• Provide technical support to manufacturing during validation and qualification activities.
• Identify and assess risks, proposing corrective actions and improvements to enhance validation processes.
• Ensure compliance with all applicable regulatory requirements, including FDA, EMA, and ICH guidelines.
• Review and approve validation data and documentation to ensure accuracy and regulatory compliance.
• Participate in audits and inspections, providing validation documentation and responding to inquiries from regulatory agencies.
• Provide training and mentorship to employees on validation processes and GMP standards.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
• 8 years of experience in GMP validation or a related field.
• Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis.
• Excellent technical writing skills with high attention to detail.
• Excellent problem-solving skills and attention to detail.
• Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
• Experience with regulatory submissions and/or inspections.
• Ability to work across teams.
• Experience in drafting and reviewing validation protocols and reports.
• Strong understanding of GMP regulations, validation principles, and industry best practices.
• Experience in a pharmaceutical or biopharmaceutical manufacturing environment.

Preferred

• 3 years of GMP manufacturing experience.
• Six Sigma or Lean certifications.