Validation Engineer

Job Title: Validation Engineer

Job Description

The Validation Engineer will support GMP manufacturing and laboratory operations at a U.S. site by leading and executing validation activities for biotech equipment and computerized systems. This role focuses on authoring, executing, and documenting validation protocols to ensure compliance with FDA and global regulatory requirements in a biotech and biopharmaceutical environment. The position offers the opportunity to contribute to an innovation-focused organization that supports pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide.

Responsibilities

• Lead, author, review, and execute validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for GMP equipment, utilities, and systems.
• Support process validation, cleaning validation, and computer system validation (CSV) activities in biologics and biotech manufacturing environments.
• Ensure all validation documentation complies with current Good Manufacturing Practices (GMP), FDA regulations, ICH guidelines, and internal procedures.
• Partner closely with manufacturing, MSAT, quality assurance, engineering, and external vendors to plan, coordinate, and execute validation activities.
• Support and document investigations, deviations, change controls, and corrective and preventive actions (CAPAs) related to validated systems and processes.
• Assist with regulatory inspections and audits by providing complete validation documentation and serving as a subject matter expert for validation topics.
• Maintain validation lifecycle documentation and ensure systems and processes remain in a continuous state of control.
• Contribute to process improvement initiatives by identifying opportunities to optimize validation approaches and enhance compliance and efficiency.
• Support biologics, fill/finish, or other GMP operations by ensuring validated status of equipment, processes, and computerized systems.
• Collaborate with cross-functional teams to implement and validate computerized systems such as DeltaV, MES, LIMS, and other GMP-related software.

Essential Skills

• Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• At least 3 years of validation experience in a biotech or biopharmaceutical GMP environment.
• Hands-on experience writing and executing validation protocols, including IQ, OQ, and PQ activities.
• Strong working knowledge of GMP regulations and validation lifecycle principles.
• Experience with equipment validation in biotech, biopharmaceutical, or pharmaceutical settings.
• Experience supporting manufacturing, fill/finish, or biologics operations.
• Proficiency in technical writing for validation documentation, including protocols, reports, and supporting records.
• Familiarity with process validation, cleaning validation, and validation testing in a GMP environment.
• Experience with computer system validation (CSV) and software validation in regulated environments.
• Ability to support investigations, deviations, change controls, and CAPAs related to validated systems.
• Knowledge of bioprocess and cGMP practices and their application to validation activities.
• Ability to collaborate effectively with MSAT, QA, engineering, manufacturing, and external vendors.

Additional Skills & Qualifications

• Exposure to biologics, cell culture, or aseptic manufacturing environments.
• Familiarity with DeltaV, MES, LIMS, or other GMP computerized systems.
• Experience working in a contract development and manufacturing (CDMO) or client-facing manufacturing environment.
• Background in biotechnology, bioprocessing, or related scientific disciplines.
• Experience in process improvement initiatives within GMP or bioprocess operations.
• Strong attention to detail and ability to maintain accurate and compliant validation records.
• Ability to support regulatory inspections and audits as a validation subject matter expert.
• Comfort working in a fast-paced, innovation-focused organization that partners with global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical clients.

Work Environment

The role is primarily based on the manufacturing floor and in laboratory settings within a GMP-regulated biopharmaceutical and biotech facility. You will work around GMP equipment, utilities, and computerized systems such as DeltaV, MES, and LIMS, supporting biologics and related manufacturing operations. The environment emphasizes safety, with clear guidelines, procedures, and standard operating procedures (SOPs) that everyone is expected to follow and uphold. The organization fosters a culture driven by passionate scientists focused on solving complex scientific problems, improving R&D productivity, accelerating time to market, and reducing innovation costs. The site represents a key U.S. operation within a larger global network, offering exposure to diverse technologies and client projects in a collaborative, cross-functional setting.

This is a Contract position based out of Baltimore, MD.

The pay range for this position is $55.00 - $62.00/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)

This is a fully onsite position in Baltimore,MD.

This position is anticipated to close on May 21, 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 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.

Salary : $55 - $62