Computer System Validation Csv Pharmaceutical Jobs in Silver Spring, MD

Job Title: Validation Engineer

Job Description

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

Responsibilities

• Manage and prioritize all phases of assigned validation projects from concept through performance qualification and ongoing support of cGMP operations.
• Ensure cGMP regulatory compliance by following site and corporate validation plans, policies, and procedures.
• Apply strong knowledge of validation practices and governmental regulations related to equipment, utility, facility, and computer system validations.
• Review and approve validation-related system lifecycle documentation, including user requirements, functional specifications, design specifications, commissioning protocols, qualification protocols, protocol deviations, and validation reports.
• Review data generated by validators for temperature mapping studies and ensure accuracy, completeness, and compliance.
• Write and execute validation protocols for equipment, processes, and computer systems, including IQ, OQ, and process validation activities.
• Lead and support equipment validation activities associated with manufacturing bulk drug substance in a single-use facility.
• Contribute subject matter expertise in Commissioning and Qualification and Computer Systems Validation (CSV), including software validation and related activities.
• Utilize validation-specific software programs and tools such as DeltaV, LIMS, and MES to support validation testing and documentation.
• Support continuous process improvement initiatives within bioprocess and manufacturing science and technology (MSAT) functions.
• Coordinate and prioritize multiple validation projects of varying complexity, ensuring timely completion and alignment with program goals.
• Collaborate effectively with cross-functional teams in biopharmaceutical, pharmaceutical, and biotech settings to support validation and compliance objectives.
• Prepare clear, accurate, and compliant technical documents and validation reports using strong technical writing skills.
• Apply knowledge of GxP regulations and current validation best practices to maintain robust and compliant validation programs.
• Demonstrate shared responsibility for safety by following established safety guidelines, procedures, and standard operating procedures in all validation activities.

Essential Skills

• Minimum of 5 years of experience in a biopharmaceutical or related environment focused on system qualification or validation.
• Bachelor of Science degree 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, utility, facility, and computer system validations.
• Subject matter expertise in Commissioning and Qualification and Computer Systems Validation (CSV).
• Demonstrated ability to write and execute validation protocols, including IQ, OQ, and process validation activities.
• Proficiency in cGMP and GxP requirements within biopharmaceutical, pharmaceutical, and biotech environments.
• Highly effective verbal and written communication skills, including strong technical writing capabilities.
• Proficiency in Microsoft Office applications and validation-specific software programs.
• Ability to think and act both strategically and tactically in planning and executing validation projects.
• Proven ability to effectively prioritize and coordinate activities across multiple concurrent projects.
• Strong problem-solving and critical thinking skills with a demonstrated ability to conduct technical programs and achieve program goals.
• Strong organizational skills to manage and delegate multiple projects at differing levels of complexity.

Additional Skills & Qualifications

• Experience in biotechnology, biologics, and bioprocess operations within biopharmaceutical or CDMO settings.
• Experience in validation within pharmaceutical, biotech, and bioprocess manufacturing environments.
• Hands-on experience with validation testing, equipment validation, process validation, and computer system validation.
• Familiarity with software validation and CSV methodologies and standards.
• Experience using or supporting systems such as DeltaV, LIMS, and MES in a validated environment.
• Exposure to manufacturing science and technology (MSAT) and process improvement initiatives.
• Ability to collaborate with multidisciplinary scientific teams and support integrated discovery, development, and manufacturing services.
• Comfort working with clients and stakeholders in pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries.

Work Environment

The role operates primarily on the manufacturing floor and in laboratory settings within a cGMP-compliant facility. The environment includes single-use bulk drug substance manufacturing, bioprocess equipment, and validated computer systems such as DeltaV, LIMS, and MES. Team members work closely with passionate scientists in a culture that emphasizes innovation, problem-solving, and improving R&D productivity. Safety is central to operations, with shared responsibility and accountability for following safety guidelines, procedures, and standard operating procedures. The work involves hands-on interaction with manufacturing and lab equipment, frequent documentation and computer-based tasks, and collaboration across technical and scientific disciplines.

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

The pay range for this position is $55.00 - $65.00/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 Aug 3, 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 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 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.