Validation Engineer

Job Description

Job Description

Job Title: Validation Engineer Job Description

The Validation Engineer manages and prioritizes all phases of assigned validation projects from concept through performance qualification and ongoing support of cGMP operations. This role ensures cGMP regulatory compliance by adhering to site and corporate validation plans, policies, and procedures. The engineer contributes at a high level to Commissioning and Qualification as well as Computer Systems Validation, supporting a dynamic biopharmaceutical manufacturing environment.

Responsibilities

• Manage and prioritize all phases of assigned validation projects from initial concept through performance qualification and ongoing cGMP support.
• Ensure cGMP regulatory compliance by adhering to site and corporate validation plans, policies, and procedures.
• Apply strong knowledge of validation and related practices, including governmental regulations associated with equipment, utility, facility, and computer system validations.
• Review and approve validation-related system lifecycle design documentation, including user requirements, functional specifications, design specifications, commissioning protocols, qualification protocols, protocol deviations, and summary reports.
• Review data generated by validators for temperature mapping studies and ensure that results meet defined acceptance criteria.
• Contribute subject matter expertise in Commissioning and Qualification (IQ/OQ/PQ) and Computer Systems Validation (CSV) for new and existing systems.
• Write and execute validation protocols for equipment, utilities, processes, and computer systems in a biopharmaceutical manufacturing setting.
• Support validation activities related to equipment associated with manufacturing bulk drug substance in a single-use facility.
• Collaborate with cross-functional teams, including MSAT and process development, to drive process improvement and ensure validated state of systems.
• Use validation-specific software and tools, including systems such as DeltaV, LIMS, and MES, to plan, document, and track validation activities.
• Coordinate multiple validation projects of varying complexity, ensuring timely completion and alignment with project goals.
• Communicate effectively with stakeholders, providing clear updates on validation status, risks, and mitigation plans.
• Apply strong problem-solving and critical thinking skills to resolve validation issues and support continuous improvement of validation practices.

Essential Skills

• Minimum of 5 years of experience in a biopharmaceutical or related environment in system qualification or validation.
• Bachelors degree (BS) in Engineering, Science, or Project/Program Management.
• Experience validating equipment associated with manufacturing bulk drug substance in a single-use facility.
• Strong knowledge of validation practices and governmental regulations related to equipment, utilities, facilities, and computer systems.
• Subject matter expertise in Commissioning and Qualification, including IQ and OQ activities.
• Subject matter expertise in Computer Systems Validation (CSV) and software validation.
• Experience writing and executing validation protocols for equipment, processes, and computer systems.
• Proficiency with cGMP and GxP requirements and their application in biopharmaceutical manufacturing.
• Highly effective verbal and written communication skills.
• Demonstrated ability to effectively prioritize and coordinate multiple activities and projects.
• Proficiency in Microsoft Office applications.
• Proficiency with validation-specific software programs and tools.
• Strong problem-solving and critical thinking skills with proven ability to conduct technical programs and achieve program goals.
• Strong organizational skills with the ability to manage and delegate multiple projects at different levels of complexity.
• Knowledge and experience in biopharmaceutical, pharmaceutical, biotech, and biologics/biotech environments.
• Experience with process validation and validation testing in a cGMP setting.

Additional Skills & Qualifications

• Experience in bioprocess operations and MSAT-related activities.
• Familiarity with CDMO (contract development and manufacturing organization) environments.
• Experience with computer system validation tools and methodologies, including CSV and software validation.
• Exposure to systems such as DeltaV, LIMS, and MES within a regulated manufacturing environment.
• Experience supporting process improvement initiatives in a cGMP environment.
• Comfort working across biotechnology, biopharmaceutical, and pharmaceutical settings.
• Ability to think and act both strategically and tactically when planning and executing validation activities.

Work Environment

This role operates primarily on the manufacturing floor and in laboratory environments within a biopharmaceutical facility. The position supports a modern single-use bulk drug substance manufacturing operation, working closely with production, MSAT, and quality teams. The organization emphasizes an innovation-focused culture driven by passionate scientists who help clients solve scientific problems, improve R&D productivity, accelerate time to market, and reduce innovation costs. Safety is central to operations, with shared responsibility and accountability for following safety guidelines, procedures, and SOPs. The environment involves regular interaction with advanced process and automation technologies, including control systems such as DeltaV and informatics platforms like LIMS and MES, in a regulated cGMP setting.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $55.00 - $65.00/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 position based out of Baltimore, MD.

Application Deadline

This position is anticipated to close on Oct 28, 2026.

Workplace Type

This is a fully onsite position in Baltimore,MD.

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.