Job Description
Job Title: QA Validation EngineerDept: QualityReport to: Validation Team Leader Responsibilities Coordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met. Coordinate, implement, and actively participate in the site Validation Program and general Quality Assurance activities. Coordinate and actively participate in the validation and quality assurance of site equipment, utilities, processes, and software in compliance with FDA, European cGMP, and GAMP standards. Generate, maintain, and execute the Site Validation Master Plan. Generate, maintain, and execute Project Validation Plans and schedules. Generate validation protocols and final reports to cGMP standards. Generate validation investigations and implement corrective actions. Create, review, and approve various quality documents and test data. Manage validation, exception events, and change control processes. Maintain and track validation equipment, if applicable. Complete all required training before executing tasks. Document all activities in line with cGMP requirements. Update validation procedures, job instructions, and batch documentation to reflect current best practices. Perform cross-training within the team and train new team members. Participate in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems. Coordinate activities to maximize the effectiveness of all team members. Maintain overall cGMP compliance of the production areas. Communicate with peers and management regarding activities in the area, including escalation of events or concerns. Requirements Essential Qualification and/or degree in engineering or a scientific discipline. Technical/Business Knowledge - Job Skills/Experience Required 3+ years of experience with cGMP, validation, and regulatory requirements relating to the biopharmaceutical industry. Strong communication (written and oral), presentation, and troubleshooting skills. Effective interpersonal and organisational skills. Ability to work both independently and in a team environment. Capable of prioritising work and multitasking. Cognitive Skills This position identifies systems and processes requiring validation/quality assurance support and ensures timely documentation, action, and resolution. Good communication and motivational abilities are required. Ownership/Accountability This role supports a positive developmental culture within the organization while ensuring compliance with Quality policies. Requires knowledge of company policies and procedures and involves working towards organizational goals. Demonstrates an ethos of "Right First Time" at all times. Adheres to procedures, policies, and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company standards. Shows tenacity to ensure issue closure. Influence/Leadership May support cross-functional teams and cost improvement projects. Persuasion and direction skills are required to influence others in areas critical to job performance. Decision Making/Impact This position impacts manufacturing, product quality, and technical performance at the site location. Supervision Received Decision making within agreed responsibilities. Activities are broadly defined by goals and company competencies with general management oversight. Supervision Provided Regular interaction with personnel at all levels of the plant. Interaction with internal and external auditors (e.g., FDA, IMB). Involvement in cross-functional activities with other site and TPM personnel. EHS Responsibilities Comply with EHS policies and procedures and demonstrate EHS best practices in all work activities. Be aware of personal and team safety, always following safety notices and barriers. Report EHS incidents and/or Near Misses (unsafe acts/conditions) immediately to your supervisor and raise events in the EHS system. Support a culture of EHS excellence by recognizing and submitting opportunities for improvement. Attend all required EHS training and medical surveillance programs. Wear PPE as required. #J-18808-Ljbffr