Validation Engineer

Get AI-powered advice on this job and more exclusive features. This role is responsible for shaping and guiding the site’s approach to validation activities, particularly those involving cleaning processes. You will serve as an engineering approver for cleaning development, validation protocols, and final reporting. The position includes planning validation strategies, coordinating execution, preparing documentation, and supporting both new and recurring validation efforts. You will also help troubleshoot manufacturing issues and evaluate opportunities for process optimization. Validation documentation may be referenced in regulatory submissions and during inspections, making accuracy and compliance crucial. Daily collaboration with Manufacturing, Engineering, Regulatory Affairs, Quality Control, and Quality Operations is expected. Key Responsibilities Apply in-depth knowledge of cGxP, GAMP5, 21 CFR Part 11, relevant SOPs, and internal procedures to guide validation activities. Manage multiple technical initiatives simultaneously in support of engineering and manufacturing groups. Lead or assist with complex projects requiring prioritization, coordination, and cross‑functional teamwork. Evaluate change controls to determine potential effects on validated systems and processes. Complete routine validation assignments with precision and timeliness. Engage with cross‑functional teams to define validation needs using lifecycle principles including user requirements, functional and design specifications, development work, and validation strategies. Write protocols and reports, ensure execution, interpret results, and confirm compliance with worldwide regulatory guidelines (e.g., FDA, EU, JP, ISO 14644, EC Annex1, USP‑NF). Mentor peers on quality engineering approaches, including statistics‑based testing and evaluation. Use tools such as FMEA, DOE, SPC, and QbD to conduct risk assessments and resolve issues. Identify opportunities to streamline validation processes or improve operational efficiency. Detect and address gaps related to validation requirements and corporate validation standards. Maintain validation plans and assessments as systems evolve. Assist with investigations, CAPA activities, and documentation updates. Support the creation or revision of SOPs to align with operational or regulatory needs. Participate in audits and inspections, ensuring timely closure of observations and presenting validation rationale when required. Contribute to corporate validation harmonization initiatives. Perform additional responsibilities as assigned by leadership. Qualifications Bachelor’s degree in an engineering field (Chemical, Mechanical, Electrical preferred). Minimum of 2 years’ experience in validation. Background in manufacturing and cleaning processes is required. Hands‑on experience developing and executing validation protocols and SOPs within a regulated pharmaceutical or biotech setting. Strong understanding of cGMP operations; direct experience in technical services, engineering, or manufacturing is beneficial. Ability to work both independently and collaboratively across technical and non‑technical groups. Demonstrated leadership, organization, and communication skills. Strong technical writing capabilities. Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Visio, and Project. Effective multi‑project management and time‑management skills. Experience with problem‑solving and root‑cause analysis techniques. About the Company Their organization is committed to advancing healthcare through innovative therapies and exceptional patient support. They offer a workplace centered on collaboration, integrity, and continuous improvement. Employees are encouraged to grow their careers through meaningful work and ongoing development opportunities. Recognized globally as an employer of choice, we strive to create an inclusive environment where every team member plays a part in delivering better health solutions worldwide. Seniority level Entry level Employment type Full‑time Job function Industries: Engineering Services and Health and Human Services #J-18808-Ljbffr