Validation Specialist

Job Description

We are hiring for a Validation Specialist in the Biotech industry here in Columbus! This role will be ensuring that new and existing laboratory equipment is properly setup and meets necessary qualifications and regulations for the industry. This will include developing validation plans and protocols, running tests to verify equipment works as intended, identifying any deviations with equipment and taking corrective action to fix it, and preparing documentation.

An ideal candidate would be an entry-level graduate with a Bachelors Degree in Chemical Engineering, Biological Engineering, or similar. We would also consider candidates with a Bachelors in a Science if you have strong experience with troubleshooting and/or calibrating equipment.

Job Title: Validation Specialist

Job Description

The Validation Specialist supports the qualification and validation of laboratory and manufacturing equipment, systems, and processes within a state-of-the-art life sciences facility. This role begins with hands-on work in temperature mapping, periodic review, pipette validation, and biosealer validation, and progresses to the validation of bioreactors over time. The Validation Specialist works across quality laboratories, cleanrooms, and warehouse areas to ensure equipment and processes meet regulatory, quality, and internal compliance standards. This position is well-suited for recent graduates or early-career professionals in life sciences or engineering who are eager to grow their expertise in equipment validation and Good Manufacturing Practice (GMP) environments.

Responsibilities

Perform temperature mapping, periodic reviews, pipette validation, and biosealer validation, gradually expanding responsibilities to include bioreactor validation.

Develop and execute equipment qualification protocols for manufacturing, processing, and filling equipment, as well as facilities and utilities that support these operations.

Support project-based validation activities, completing one project before moving to the next, such as validating multiple pieces of laboratory equipment for new cleanroom openings.

Analyze data generated by validation studies using statistical methods to determine process capabilities and assess performance.

Gather and organize relevant documentation, including executed batch records, certificates of analysis, equipment logs, equipment qualifications, and raw material certificates of analysis.

Investigate and resolve deviations or exceptions from predefined acceptance criteria identified during validation and qualification activities.

Draw conclusions from data, observations, deviations, exceptions, and investigations to determine whether a process is considered valid.

Review calibration and qualification records supplied by third-party vendors to ensure completeness, accuracy, and compliance.

Author and review department standard operating procedures (SOPs) to support validation and qualification activities.

Author, review, and execute User Requirements Specifications (URS), Functional Design Specifications (FDS), Risk Assessments (RA), Design Qualifications (DQ), and qualification test protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Write clear and comprehensive summary reports and closeout reports for validation and qualification protocols in accordance with established validation and qualification procedures and policies.

Maintain protocols and system documentation in an orderly library so that information can be readily provided to regulatory bodies when required.

Ensure that protocols, verifications, validation plans, and summary reports generated during validation and qualification activities are stored and archived according to internal procedures.

Maintain current knowledge in compliance, validation, and relevant regulatory requirements by engaging with quality assurance, quality control, regulatory sources, professional periodicals, and appropriate training programs.

Work proactively to uphold a high level of compliance in all validation-related activities and recommend improvements where appropriate.

Develop and execute cleaning validation and verification protocols for manufacturing and processing equipment to ensure consistent and compliant operations.

Qualifications

Education in a relevant discipline such as Life Science, Chemical Engineering, Biomedical Engineering, or Biochemical Engineering.

Open to entry-level graduates or individuals with 0–2 years of industry experience.Job Type & Location

This is a Permanent position based out of Columbus, OH.Pay and Benefits

The pay range for this position is $24.00 - $26.00/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 Columbus,OH.Application Deadline

This position is anticipated to close on Jun 1, 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 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 process due to a disability, please email 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.

Full-time