Validation Engineer

Job Title:

Validation Engineer II Job Description The Validation Engineer II develops and executes validation and commissioning protocols for general equipment in a biopharmaceutical manufacturing facility. This role focuses on equipment qualification activities in a cGMP environment, ensuring compliance with FDA guidelines, internal procedures, and industry best practices. The engineer collaborates closely with cross-functional teams to support change management, project documentation, and effective communication throughout the project lifecycle. Responsibilities Develop, review, and update User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Design Description Specifications (DDS) to ensure they accurately reflect system and equipment needs. Perform and support the execution of validation protocols and projects for general equipment in a biopharmaceutical facility, ensuring adherence to cGMP and internal standards. Prepare and execute commissioning documents to verify that equipment and systems are installed and functioning according to design and regulatory requirements. Prepare and execute Installation and Operational Qualification (IOQ) documents, including drafting and performing test scripts and recording results in a controlled and compliant manner. Generate clear and comprehensive IOQ summary reports that document testing outcomes, deviations, and conclusions, and provide recommendations as needed. Maintain complete and accurate project lifecycle documentation in accordance with internal procedures and client procedures, ensuring traceability and audit readiness. Support the change management process by assessing the impact of proposed changes on validated systems and equipment and by updating validation documentation accordingly. Support project-level customer communications and coordination efforts, including status updates, clarification of requirements, and alignment on validation strategies. Apply a solid understanding of FDA validation guidelines, GDP, and industry best practices to daily work, ensuring that validation standards are consistently implemented. Collaborate with cross-functional teams to address validation issues, resolve discrepancies, and ensure timely completion of validation activities. Contribute to the qualification and validation of parts washers and cleaning processes when applicable, supporting cleaning validation efforts. Ensure that all validation and documentation activities comply with applicable regulations, including 21 CFR Parts 210, 211, and 11. Essential Skills Bachelor's degree in engineering, science, or a related field with at least three (3) years of experience in equipment qualification in a biotechnology or pharmaceutical cGMP environment, or a Master's degree in engineering, science, or a related field with at least two (2) years of relevant experience. Demonstrated experience in equipment validation, including development and execution of IQ, OQ, and PQ protocols. General knowledge of biopharmaceutical equipment and its application in cGMP manufacturing environments. Solid understanding of FDA validation guidelines, Good Documentation Practices (GDP), and industry best practices, with the ability to implement validation standards in daily activities. Working knowledge of 21 CFR Parts 210, 211, and Part 11 and their application to equipment qualification and validation documentation. Experience with change control processes in the pharmaceutical or biotechnology industry. Familiarity with various equipment used in pharmaceutical and biotech manufacturing areas. Strong organizational skills with the ability to manage multiple validation tasks and documentation requirements simultaneously. Excellent written and verbal communication skills for preparing technical documents and interacting with project stakeholders. Strong interpersonal skills to collaborate effectively with cross-functional teams and client representatives. Additional Skills & Qualifications Experience with parts washers and cleaning validation in a pharmaceutical or biotechnology setting is highly desired. Prior involvement in commissioning activities for biopharmaceutical equipment and systems. Experience preparing and redlining URS, FRS, and DDS documents to refine and clarify system requirements. Ability to interpret and apply cGMP, FDA, and internal procedural requirements to practical validation scenarios. Attention to detail and a high level of accuracy in generating and maintaining validation and lifecycle documentation. Ability to work independently while also contributing effectively within a project team environment. Work Environment This position is 100% onsite in a biopharmaceutical manufacturing environment with no remote work. The role involves working within cGMP-regulated facilities, closely interacting with production and engineering areas and with various types of biopharmaceutical equipment. Work includes time in office settings for documentation and protocol development, as well as time on the manufacturing floor for commissioning and qualification activities. The environment emphasizes regulatory compliance, meticulous documentation, and collaboration with cross-functional teams throughout the project lifecycle. Job Type & Location This is a Contract to Hire position based out of Andover, MA. Pay and Benefits The pay range for this position is $50.00 - $55.00/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) Workplace Type This is a fully onsite position in Andover,MA.

Application Deadline This position is anticipated to close on May 7, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.