Job Title: QA Validation Engineer
Dept: Quality
Report 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.