We are looking to hire a Validation Engineer immediately. The Validation Engineer is responsible for managing, inspecting, testing, and modifying the instrumentation, equipment, mechanics, and procedures used to manufacture products in accordance with all company Standard Operating Procedures and manufacturing instructions, and to ensure all systems and processes are running correctly and efficiently to produce high quality products. The candidate will also be responsible for generating and executing the site validation master plan. This position has no direct reports.
RESPONSIBILITIES:
Performs validation studies on manufacturing equipment, including equipment set up and qualification, manufacturing process validation, as well as cleaning validation, and ensuring systems remain in a qualified, operational state of compliance associated with cGMP manufacturing work environment.
Generates, reviews, and executes the master validation plan, validation protocols (IQ, OQ, PQ) on equipment, utilities, and computerized systems ensuring compliance with cGMP.
Prepares all implementation of change request using the "Change Management Request" (CMR) process initiated internally or from customers by collecting all relevant documentation, initiating a change request, route for approvals, implement the plan and close the request accordingly.
Apply concepts of Continuous Monitoring through Statistical Process Control (SPC) to ensure the processes that have been transferred into production are monitored and controlled appropriately to maintain the equipment in a validated state.
Prepares protocols, reports, and other necessary documentation for validation to determine whether systems and processes meet required criteria and specifications; identifies root causes of production or equipment problems
Evaluating current equipment and procedures used in production to certify operations are within regulations
Investigates and conducts troubleshooting and root cause analysis of validation related incidents and deviations
Resolve CAPA's, non-conformances, protocol incidents, and change controls related to validation protocols
Generate data and reports for the validation periodic monitoring and re-qualification programs
Establish validation standards, develop testing protocols, prepare equipment, document test results and analyze results to ultimately determine if a new process or new equipment meets policies and standards.
Communicate with outside vendors to identify new equipment or perform equipment troubleshooting if problems arise.
Maintains validation documentation through the validation lifecycle including protocols, , deviations and corrective actions.
Perform risk assessments, failure mode effects analysis (FMEA), and statistical data analysis to support validation activities.
Represents the engineering process during customer, certification and regulatory audits (internal and external)
Assist in investigating deviations related to facilities, utilities, and equipment.
Participates in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines; says current with regulatory trends and validation best practices to enhance validation strategies.
Write new and revise current Standard Operating Procedures (SOPs) and Work Instructions as needed.
Other duties as assigned by management.
QUALIFICATIONS:
Required
BS in Engineering (Chemical preferred), life sciences or related field.
3+ years of validation work experience in a pharmaceutical and/or medical device industry.
Certified Quality Engineer/Validation professional a plus
Experience with validation of cleaning, software, automated systems, packaging and laboratory equipment desired.
Experience authoring and executing Validation protocols such as Installation and equipment operation.
Strong understanding of FDA regulations, cGMP, ISO 13485, ICH guidelines and risk management principles.
Proficiency in validation software, statistical analysis tools, and data integrity principles is a plus.
Strong problem-solving skills with the ability to analyze technical issues and propose solutions.
Excellent interpersonal, communication and documentation skills.
Ability to work independently and in cross-functional teams in a fast-paced environment.
Preferred
Must have the ability to work both independently and as a greater team. Must be able to coordinate work with customers, supervisors, and information partners frequently in different states and/or countries.
Must be able to work in a fast-paced environment. Must be able to manage multiple projects while minding priorities. Must be able to make informed, strategic decisions, even when under pressure or when working with resource limitations.
Must always have a mindset to protect the interests and health of our consumers, our company, and our customers.
Must work well cross-functionally, with partners from commercial, sales, supply chain, marketing, operations, etc.
Ability to work with limited supervision and take ownership of projects to meet scheduled timeline and technical goals; maintains accurate and thorough records
Experience writing SOPs and technical writing.
Ability to lead continuous quality system improvements for the validation program.
Data analysis such as Six-Sigma; ability to work in a cross-functional team environment Note: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position.
Experience Level
Intermediate Level
Job Type & Location
This is a Contract to Hire position based out of Dallas, TX.
Pay and Benefits
The pay range for this position is $48.00 - $57.00/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 Dallas,TX.
Application Deadline
This position is anticipated to close on Jul 26, 2026.
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.
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.
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.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
