What are the responsibilities and job description for the Process Validation Engineer position at Actalent?
The overall goal of the Process Validation Engineer is to ensure that all manufacturing processes, both internal and outsourced, used by the company to manufacture medical devices are validated to ensure product quality and compliance with federal regulations and industry standards, including but not limited to 21 CFR 820 and ISO.
Responsibilities
- Ensure that facilities, processes, and equipment used in support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.
- Coordinate validation activities with other sites, departments, and subcontractors.
- Maintain the validation master plan to ensure that routine re-validations and project-related validations are completed on time.
- Analyze data, procedures, and requirements with consideration given to company goals.
- Apply basic risk management principles to all activities and tasks.
- Identify areas for process improvement and provide supporting information for change, including reasons and justifications.
- Participate in the development or modification of validation packages and deliverables, including risk assessments, plans, requirements, and protocols.
- Work directly with suppliers to ensure validations are performed correctly and documented completely.
- Work independently with objectives given by the Project Manager.
- Plan and coordinate own work according to higher-level project schedules.
- Review documentation for accuracy, clarity, consistency, completeness, and compliance for multiple projects.
- Report unexpected events, issues, or delays to the project team and management.
- Maintain schedule and drive to meet validation schedule as aligned with project goals.
- Perform other assigned responsibilities upon request.
Essential Skills
- Validation protocols
- OQ
- IQ
- GMP
- Process validation
- Validation testing
- Medical device validation
- Equipment validation
- Engineering
- Quality assurance
- Method validation
- FDA regulations
- Equipment qualification
- Sterilization
Additional Skills & Qualifications
- Bachelor’s degree in engineering or equivalent work experience.
- Knowledge of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11/Annex 11.
- Project experience in validation testing practices, methodologies, and techniques, particularly in testing medical devices.
- Experience leading test engineer teams is a plus.
- Ability to work independently and in a team environment.
- Knowledgeable of company products and the orthopedic shoulder industry.
- Strong analytical and problem-solving skills.
- Demonstrated accuracy and attention to detail.
- Excellent oral and written communication skills.
- Proficiency with MS Office products, specifically Word and Excel.
Pay and Benefits
The pay range for this position is $38.00 - $50.00
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Dallas,TX.
Application Deadline
This position will be accepting applications until Jan 22, 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.
Salary : $38 - $50
