Validation Engineer Manager

Validation & Qualification:

Develop and execute Facility, Utility, and Equipment Qualifications.Develop and execute Performance Qualifications and Process Validations.Develop, execute, and maintain a robust Cleaning Validation program.Develop, execute, and maintain a robust Computer System Validation program.

General:

Develop, update, maintain SOPs and provide training as appropriate.Aid Process Engineering, Quality Assurance, Production, and other SMEs in the development and execution of pFMEAs.Aid other departments in process trials, validation runs, and pilot batches to establish reliable manufacturing processes for new formulations.

Project Management:

Lead and manage multiple validation projects simultaneously, ensuring on-time completion.Prepare and present technical reports, project updates, and validation metrics to senior management.

Compliance & Quality:

Ensure qualification and validation processes comply with regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards.Support quality assurance initiatives by conducting risk assessments, participating in audits, and implementing corrective actions as necessary.

Equipment & Facility Support:

Provide technical support for the selection, installation, and qualification of manufacturing equipment and for the development process related documentation (i.e. batch records).

Skills

Equipment validation, Pharmaceutical, process validation, Quality engineering, regulatory, risk assessment, equipment qualification, performance qualification, validation, gmp, cgmp, fda, system validation

Top Skills Details

Equipment validation, Pharmaceutical, process validation

Additional Skills & Qualifications

Required Education and ExperienceBachelor’s degree in chemistry or other physical science or a related field.Minimum of 10+ years of experience in pharmaceutical and/or personal care validation, with at least 5 years in Rx or OTC manufacturing.Demonstrated expertise in the development, execution, and maintenance of validation systems.Strong knowledge of cGMP, FDA regulations, and OTC compliance standards.

Preferred Education and Experience

Master’s Degree preferred.

Lean Six Sigma certification (Green Belt or higher) is a plus.

Working knowledge or background in the pharmaceutical care industry.Working knowledge of industry best practices for risk assessmentWorking knowledge of Facility, Utility and Equipment Qualification requirementsWorking knowledge of Process Performance Qualification and Process Validation requirements.Working knowledge of Computer System Validation Requirements.Working knowledge of Cleaning Validation Requirements.Strong technical and/or regulatory expertise.Detailed record keeping and communication of results to others.Project skills appropriate for leadership of validation projects.Excellent written, verbal, and interpersonal communication skills.High level of initiative, innovation, critical thinking, and problem-solving skillsAbility to work cross-functionally & at all levels within the organization including senior leadership.Ability to prioritize multiple responsibilities and manage deadlines accordingly.Communicate effectively and professionally both internally and externally.Exceptional attention to detail and high level of accuracy & organization.Ability to work as part of a team and excel independently in fast-paced environment.Ability to adapt quickly to changing circumstances.Demonstrated leadership skills.Proficient with Microsoft Office

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $80000.00 - $140000.00/yr.

Health, Dental, Vision, Short Term Disability, Long Term Disability, Life Insurance, Critical Care Insurance, Accident Insurance, PTO, Sick Leave, Parental Leave, 401(k)

Workplace Type

This is a fully onsite position in Saint Paul,MN.

Application Deadline

This position is anticipated to close on Apr 11, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.