Validation Specialist

ACTalent; Boca Raton (FL); On-site; USD 50,000 - 63,000; Full time

Benefits offered by this job

Medical, dental & vision

Life Insurance

401(k) retirement plan

Disability insurance

Health Savings Account (HSA)

Paid time off

Job summary

ACTalent is seeking a Validation Specialist in Boca Raton, FL to develop, execute, and maintain validation programs ensuring equipment, utilities, processes, and systems meet FDA/cGMP standards. The role supports sterile injectable manufacturing and helps maintain regulatory compliance and inspection readiness.

You will perform IQ/OQ/PQ, create Validation Master Plans and URS, and collaborate with Engineering, Production, QC, Microbiology, and QA teams. Contract-to-hire with onsite work.

Qualifications

• Bachelors degree in Chemistry, Microbiology, Biotechnology, Engineering, Pharmacy or related field is required.
• Minimum 5+ years of validation experience in pharmaceutical manufacturing.
• Hands-on experience supporting sterile injectable manufacturing environments.
• Experience with equipment, utility, process, and cleaning validation.
• Familiarity with FDA cGMP and 21 CFR Parts 210/211, and Annex 1 sterile requirements.
• Strong writing, analytical, and problem-solving skills; data integrity awareness (ALCOA+).

Responsibilities

• Perform IQ/OQ/PQ validation activities for manufacturing systems and equipment.
• Develop and maintain Validation Master Plans, URS, protocols, and final reports.
• Support qualification of HVAC, WFI, purified water, clean steam, and environmental monitoring.
• Execute process validations, media fills, cleaning validations, and requalification.
• Conduct risk assessments, investigate deviations, and support change controls.
• Review validation data and ensure compliant documentation practices.
• Collaborate with Engineering, Production, QC, Microbiology, and QA teams.
• Support commissioning, regulatory inspections, internal audits, and continuous improvement.
• Ensure compliance with FDA regulations, cGMP, data integrity, and company procedures.

Skills

Quality assurance

Validation

Sterile manufacturing

ALCOA+

FDA CFR 210/211

IQ/OQ/PQ

Cleaning Validation

Microbiology

Biotechnology

Education

Bachelor's degree in a scientific field

Tools

CSV

Job description

Job Description

The Validation Specialist is responsible for developing, executing, and maintaining validation and qualification programs that ensure manufacturing equipment, utilities, processes, and systems meet FDA, cGMP, and company standards. This role supports sterile injectable manufacturing operations and helps maintain regulatory compliance and inspection readiness.

Job Title: Validation Specialist

Job Description

The Validation Specialist is responsible for developing, executing, and maintaining validation and qualification programs that ensure manufacturing equipment, utilities, processes, and systems meet FDA, cGMP, and company standards. This role supports sterile injectable manufacturing operations and helps maintain regulatory compliance and inspection readiness.

Responsibilities

• Perform equipment qualification activities, including IQ/OQ/PQ protocols for manufacturing systems and production equipment.


• Develop and maintain validation documentation such as Validation Master Plans, User Requirements Specifications, protocols, and final reports.


• Support qualification of critical utilities including HVAC, WFI, purified water, clean steam, compressed air, and environmental monitoring systems.


• Execute process validations, media fills, cleaning validations, and requalification activities.


• Conduct risk assessments, investigate validation deviations, and support change control evaluations.


• Review validation data and ensure accurate, compliant documentation practices.


• Collaborate with Engineering, Production, Quality Control, Microbiology, and Quality Assurance teams.


• Support commissioning, regulatory inspections, internal audits, and continuous improvement initiatives.


• Ensure compliance with FDA regulations, cGMP requirements, data integrity standards, and company procedures.

Essential Skills

• Quality assurance


• Validation


• Sterile and sterility


• Injectable manufacturing


• ALCOA+ principles


• 21 CFR Part 210/211


• Cleaning Validation


• Microbiology


• Chemistry


• Biotechnology


• IQ/OQ/PQ protocols

Additional Skills & Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biotechnology, Engineering, Pharmacy, or a related scientific field


• 5+ years of validation experience within pharmaceutical manufacturing


• Hands-on experience supporting sterile injectable manufacturing environments


• Equipment, utility, process, and cleaning validation


• FDA cGMP regulations and 21 CFR Parts 210/211


• Annex 1 sterile manufacturing requirements


• Risk assessments, deviation investigations, and change controls


• Computer System Validation (CSV)


• Strong technical writing, analytical, and problem-solving skills


• Knowledge of data integrity principles (ALCOA+)

Work Environment

The work environment adheres to cGMP standards and involves working in clean rooms.

Job Type & Location

This is a Contract to Hire position based out of Boca Raton, FL.

Pay And Benefits

The pay range for this position is $36.06 - $45.67/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

This is a Contract to Hire position based out of Boca Raton, FL.

Application Deadline

This position is anticipated to close on Nov 24, 2026.

Workplace Type

This is a fully onsite position in Boca Raton,FL.

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 [e-mail] 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 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.