About this role
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 & LocationThis is a Contract to Hire position based out of Andover, MA.
Pay and BenefitsThe 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)
Application DeadlineThis position is anticipated to close on Nov 25, 2026.
Workplace TypeThis 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 [email protected] 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.