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 complex biopharmaceutical manufacturing operations and driving continuous improvement in validation practices.

Responsibilities

• Manage and prioritize all phases of assigned validation projects from initial concept through performance qualification and ongoing support of cGMP operations.
• Ensure cGMP regulatory compliance by following site and corporate validation plans, policies, procedures, and applicable GxP requirements.
• Apply strong knowledge of validation and related practices, including governmental regulations associated with equipment, utility, and facility validations, as well as 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 validation reports.
• Review data generated by validation personnel for temperature mapping studies and ensure the accuracy, completeness, and compliance of results.
• Contribute subject matter expertise in Commissioning and Qualification (C&Q) activities, including IQ/OQ execution and documentation for equipment and utilities.
• Lead or support Computer Systems Validation (CSV) and software validation efforts, ensuring systems such as DeltaV, LIMS, and MES meet regulatory and internal quality requirements.
• Write, review, and execute validation protocols for equipment validation, process validation, and validation testing in a biopharmaceutical or biotech environment.
• Support validation activities associated with manufacturing bulk drug substance in a single-use facility, ensuring systems and processes perform as intended.
• Collaborate with cross-functional teams, including MSAT and bioprocessing groups, to improve processes and enhance validation strategies.
• Effectively prioritize and coordinate multiple validation activities and projects at varying levels of complexity to meet program goals and timelines.
• Use strong problem-solving and critical thinking skills to troubleshoot validation issues, propose solutions, and implement corrective and preventive actions.
• Prepare clear, concise technical documentation and communicate validation findings and recommendations to stakeholders through verbal and written communication.
• Utilize validation-specific software and Microsoft Office applications to manage documentation, track project progress, and maintain accurate records.
• Maintain up-to-date knowledge of current validation best practices, industry standards, and regulatory expectations, and apply them to ongoing validation programs.

Essential Skills

• Minimum of 5 years of experience in a biopharmaceutical or related environment in the area of 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 associated with equipment, utility, and facility validations, as well as computer system validations.
• Subject matter expertise in Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV).
• Proven ability to write and execute validation protocols for equipment validation, process validation, and validation testing.
• Hands-on experience with cGMP operations and a solid understanding of GxP requirements.
• Highly effective verbal and written communication skills for technical and cross-functional collaboration.
• Demonstrated ability to effectively prioritize and coordinate multiple activities and projects.
• Proficiency in Microsoft Office applications and validation-specific software programs.
• Strong problem-solving and critical thinking skills with the ability to conduct technical programs and achieve program goals.
• Strong organizational skills to handle and delegate multiple projects at differing levels of complexity.
• Knowledge of current validation best practices and regulatory expectations in biopharmaceutical, pharmaceutical, biotech, and bioprocess environments.

Additional Skills & Qualifications

• Experience in biotechnology, biologics, or biopharmaceutical manufacturing environments.
• Experience in validation within CDMO or contract development and manufacturing settings.
• Familiarity with process improvement initiatives in MSAT or related technical support functions.
• Experience with IQ/OQ activities and documentation for equipment and utilities.
• Experience in process validation and validation testing for bioprocess operations.
• Experience with Computer Systems Validation (CSV) and software validation, including systems such as DeltaV, LIMS, and MES.
• Exposure to or understanding of LIMS and MES systems in a regulated environment.
• Comfort working across pharmaceutical, biotech, and related life sciences industries.
• Ability to think and act both strategically and tactically in a fast-paced, growth-oriented environment.

Work Environment

The role operates primarily on the manufacturing floor and in laboratory environments within a cGMP biopharmaceutical facility. You will work closely with manufacturing, MSAT, and quality teams in areas where bulk drug substance is produced using single-use technologies. The environment is highly regulated and safety-focused, with strict adherence to safety guidelines, procedures, and standard operating procedures. Work may involve time in cleanroom or controlled areas, around complex process equipment, utilities, and computer-based control systems such as DeltaV, LIMS, and MES. The culture emphasizes scientific excellence, collaboration, and innovation, with a strong focus on helping clients solve technical challenges, improve R&D productivity, and accelerate time to market while maintaining high standards of compliance and quality.

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

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)

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

This position is anticipated to close on Nov 23, 2026.

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 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 View email address on ziprecruiter.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.