Validation Engineer

ACTalent; Andover (MA); Presencial; USD 59.000 - 73.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Descripción de la vacante

Actalent is seeking a Validation Engineer for a contract-to-hire role in Andover, MA. You will develop and execute validation protocols for general Biopharma equipment, apply cGMP/GDP standards, and support URS/FS analyses.

Responsibilities include IOQ/PQ documentation, change-management support, and maintaining lifecycle records per client procedures. Candidates should have a Bachelor's or Master's in engineering or science with 2–3 years in equipment qualification in biotech/pharma.

Formación

• Bachelor's or higher degree with biotech/pharma cGMP exposure.
• Solid understanding of FDA validation guidelines, GDP, and industry best practices.
• Experience with IQ/OQ/PQ and validation protocols.
• Client-facing consulting or project experience is a plus.

Responsabilidades

• Develop and execute validation protocols for general equipment in Biopharma facilities.
• Develop, review, and redline URS/FRS/DDS.
• Support change management processes.
• Prepare and execute IOQ documents and summary reports.
• Maintain project lifecycle documentation per procedures.

Conocimientos

cgmp

change control

commissioning

equipment qualification

iq

oq

pq

validation protocol

aseptic processing

cleaning validation

fill finish

packaging line

Educación

Bachelor's degree in engineering or science

Master's degree in engineering or science

Descripción del empleo

Description

The Validation Engineer is responsible for development and execution of validation and commissioning protocols for general equipment in Biopharma facility. The position requires general knowledge of Biopharmaceutical equipment, cGMP, and GDP. Duties: Perform and support execution of validation protocols/projects Develop, review, and redline URS/FRS/DDS Support change management process Support project level customer communications and coordination efforts Prepare and execute commissioning documents Prepare and execute IOQ documents and summary reports Maintain project lifecycle documentation in accordance with Mangan Biopharm internal procedures and client procedures

Skills

• cgmp
• change control
• commissioning
• equipment qualification
• iq
• oq
• pq
• validation protocol
• aseptic processing
• cleaning validation
• fill finish
• packaging line

Top Skills Details

• cgmp
• change control
• commissioning
• equipment qualification
• iq
• oq
• pq
• validation protocol

Additional Skills & Qualifications

Bachelors degree in engineering, science, or related field with at least (3) years of experience or Masters degree in engineering, science, or related field with two (2) years of experience in equipment qualification in Biotechnology or Pharmaceutical cGMP environment Must possess a solid understanding of FDA validation guidelines, GDP, and industry best practices and be able to implement validation standards daily Working knowledge of 21CFR 210, 211 and Part 11 Excellent organizational, communication, and people skills Experience working in a client-facing consulting or project environment

Experience Level

Intermediate Level

Job Type & Location

This is a Contract to Hire position based out of Andover, MA.

Pay and Benefits

The pay range for this position is $43.00 - $53.00/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 Andover, MA.

Application Deadline

This position is anticipated to close on Nov 25, 2026.

Workplace Type

This is a fully onsite position in Andover,MA.

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 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.