The Process Validation Engineer will be responsible for drafting, reviewing, and overseeing the execution of process and cleaning validation documentation.
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
- Strong written and verbal communication skills to effectively interact with internal teams, management, and regulatory bodies.
- Excellent technical writing skills with high attention to detail
- Proficiency in Microsoft Word and Excel
- 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.
- Minimum 5 years of experience in GMP validation or a related field, with at least 3 years of GMP manufacturing experience preferred.
- Knowledge of process and cleaning validation activities, including test methods, execution, and data analysis.
- 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.
- Experience in a pharmaceutical or biopharmaceutical manufacturing environment.
- Experience working in a GMP setting
- Experience with controlled documentation
Preferred- 8 years of experience in GMP validation or a related field
- Six Sigma or Lean certifications are a plus.
Wisconsin pay range
$90,000-$120,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
