Senior Validation Engineer - Actalent : Job Details

The Validation Engineer will play a crucial role in commissioning and qualification efforts for equipment, utilities, and processes. This position requires consulting with site technical services for process and cleaning validation, while reporting to the Director of Manufacturing Engineering. Responsibilities include leading all validation activities and maintaining the validation master plan for the site. Manage and/or lead the validation team in all CQV activities to meet site goals and timelines. Create commissioning, qualification, and validation documentation, including user requirement specification, design qualification, protocols, and final summary reports. Conduct commissioning, qualification, and validation according to approved corporate standards and protocols. Collaborate with the system owner to define user requirements and establish an appropriate CQV strategy. Support quality systems such as change control, deviations, CAPA, audits, quality metrics, and annual product reviews.

Essential Skills:

• Proven experience in pharmaceutical and biotech environments.
• Expertise in validation testing and protocols.
• Knowledge in process validation and equipment validation.
• Excellent technical writing skills.

Additional Skills & Qualifications:

• Bachelor's or Master's degree in a scientific discipline or related field.
• Minimum of 5 years of experience in commissioning, qualification, and validation of cGMP or cGXP.
• Specific knowledge of biological and pharmaceutical cGMPs (USDA and EU).
• Strong verbal, written, interpersonal, organizational, and communication skills.

Pay and Benefits:

The pay range for this position is $52.00 - $65.00/hr. 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 Elwood, KS. Application Deadline: This position is anticipated to close on Aug 1, 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. 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 due to a disability, please email [email protected] for other accommodation options.