Description

The overall goal of the Process Validation Engineer is to ensure that all manufacturing processes (internal and outsourced) used by the company to manufacture medical devices are validated such as to ensure product quality and compliance with federal regulations and industry standards including, but not limited to, 21 CFR 820 and ISO 13485.

Principal duties and Responsibilities:

•\tEnsure that facilities, processes, and equipment used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.

•\tCoordinate validation activities with other sites, departments, and subcontractors.

•\tMaintains the validation master plan to ensure that routine re-validations and project-related validations are completed on time.

•\tAnalyzes data, procedures, and requirements with consideration given to company goals.

•\tApplies basic risk management principles to all activities and tasks.

•\tIdentifies areas for process improvement and provides supporting information for change, including reasons and justifications.

•\tParticipates in the development or modification of validation packages and deliverables, including risk assessments, plans, requirements, and protocols.

•\tWork directly with suppliers to ensure validations are performed correctly and documented completely.

•\tWorks independently with objectives given by the Project Manager.

•\tCan plan and coordinate own work according to higher level project schedules.

•\tReview documentation for accuracy, clarity, consistency, completeness, and compliance for multiple projects.

•\tReport unexpected events, issues, or delays to the project team and management.

•\tMaintain schedule and drive to meet validation schedule as aligned with project(s) goals.

•\tOther assigned responsibilities upon request

Skills

Validation, Validation protocols, Pq, Oq, Iq, Gmp, Process validation, Validation testing, Medical device, Equipment validation, Engineering, Quality assurance, Iso 13485, Method validation, Fda, Equipment qualification, sterilization

Top Skills Details

Validation,Validation protocols,Pq,Oq,Iq,Gmp,Process validation,Validation testing,Medical device,Equipment validation,Engineering,Quality assurance,Iso 13485,Method validation,Fda,Equipment qualification,sterilization

Additional Skills & Qualifications

Qualifications and Requirements:

•\tBachelor’s degree in engineering or equivalent work experience.

•\tKnowledge of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11/Annex 11.

•\tProject experience in validation testing practices, methodologies, and techniques, particularly in testing medical devices or experience leading test engineer team is a plus.

•\tAble to work independently and in a team environment.

•\tAbility to be knowledgeable of the company products and the orthopedic shoulder industry.

•\tPossess strong analytical and problem-solving skills and demonstrated accuracy and attention to detail.

•\tMust have excellent oral and written communication skills.

•\tProficiency with MS Office products, specifically Word and Excel.

Experience Level

5+ Years' experience

Pay and Benefits

The pay range for this position is $38.00 - $50.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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 23, 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.