Job Title: Sr. Validation Engineer

Job Description

We are seeking an experienced Sr. Validation Engineer with strong experience in validation documentation authoring, GMP lab systems, and equipment validation. The ideal candidate will be responsible for ensuring that systems and applications meet their requirements as outlined in system specifications, adhering to the validation plan for each project.

Responsibilities

• Author validation documentation including validation plans, user requirements specifications, risk assessments, IQ-OQ-PQ protocols, trace matrices, and summary reports.
• Validate GMP lab systems and equipment.
• Ensure systems/applications meet requirements as outlined in system specifications (URS/FRS).
• Identify and escalate project risks and issues to the CSVC Manager.
• Engage in multiple CSVC projects, assimilate data, establish facts, and draw valid conclusions.
• Prepare reports on defects and problems arising during system testing.
• Communicate effectively both orally and in writing.
• Work as part of a team to meet deadlines and handle changing priorities.
• Exercise strong judgment capabilities to clarify requirements when necessary.
• Collaborate with cross-functional teams.
• Work with business representatives to ensure test cases reflect business rules and processes.
• Serve as a subject matter expert for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

Essential Skills

• Pharmaceutical validation protocols
• Equipment validation
• Process validation
• Technical writing
• CSV
• GMP/Regulated lab experience
• More than 5 years of CSV experience
• Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)

Additional Skills & Qualifications

• BS in Science, Engineering, or Technical Writing
• Highly skilled in computerized system testing and validation in the healthcare industry
• Solid project organizational skills and ability to multi-task
• Strong analytical problem-solving skills
• Excellent written, verbal, and listening communication skills
• Self-motivated, detail-oriented, and able to work independently without close supervision

Work Environment

This is an on-site position working on farms, labs, and manufacturing floors in St. Joe. The facility is security-guarded.

Pay and Benefits

The pay range for this position is $60.00 - $75.00/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 Saint Joseph,MO.

Application Deadline

This position is anticipated to close on Mar 25, 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 : $60 - $75