Software Validation Engineer

Responsibilities

• Author NonProduct Software Validation quality records in accordance with regulations, standards, and corporate procedures.
• Act as a subject matter expert for 21 CFR Part 820, ISO standards, and 21 CFR Part 11/Annex 11.
• Evaluate quality records for compliance and deliver constructive feedback to authors.
• Coach coworkers on regulatory compliance and applicable governing procedures.
• Perform approver roles including Change Initiator, Quality Representative, Business Process Owner, and Technical System Owner.
• Manage multiple concurrent projects, ensuring all deliverables are completed and maintaining visibility into progress.

Essential Skills

• Experience in software validation and quality assurance.
• Proficiency in authoring quality records for QMS NPSW.
• Expertise in regulatory standards such as 21 CFR Part 820 and ISO.
• Ability to evaluate and provide feedback on quality records.
• Experience in managing cross-functional teams.

Additional Skills & Qualifications

• Experience with systems like PLM (Product Lifecycle Management) and ERP (Engineering Resource Planning).
• Ability to coach and mentor coworkers on compliance.
• Capability to perform in various approver roles.

Work Environment

The work environment involves managing multiple projects and facilitating cross-functional teams. The role may require adapting to different systems and ensuring compliance with corporate procedures.

Job Type & Location

This is a Contract position based out of Minneapolis, MN.

Pay And Benefits

The pay range for this position is $50.00 - $70.00/hr.

Requirements

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)

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.