Life Science Validation Engineer

Job Description
Life Science Validation Engineer
At Accenture Industry X, we embrace change to reimagine the products and services of the future. We combine deep engineering, manufacturing, and digital expertise to revolutionize how products are designed, engineered, and manufactured. Our integrated approach leverages data and cutting-edge technologies like AR/VR/XR, cloud, AI, 5G, robotics, and digital twins to deliver more connected, efficient, and sustainable solutions.

As a Life Science Validation Engineer, you will play a critical role in ensuring the quality and compliance of processes, equipment, and systems used in the life science industry. You will be responsible for designing, executing, and documenting validation protocols to ensure that systems and processes meet regulatory requirements and industry standards. This role requires strong attention to detail, analytical skills, and knowledge of validation principles and practices in the life science sector.

Key Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, utilities, facilities, and computerized systems used in the life science industry.
• Perform risk assessments and impact analyses to determine validation requirements and priorities.
• Collaborate with cross-functional teams including engineering, quality assurance, and production to ensure validation activities are completed in accordance with project timelines.
• Review and approve validation documentation, including protocols, reports, and deviations, ensuring compliance with regulatory requirements and company standards.
• Investigate and resolve discrepancies or issues identified during validation activities, working closely with relevant stakeholders to implement corrective and preventive actions.
• Maintain validation documentation and records in accordance with regulatory guidelines and company procedures.
• Stay informed about regulatory requirements, industry trends, and best practices related to validation in the life science sector.
• Provide guidance and support to internal teams on validation-related matters, including interpretation of regulations and standards.

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Qualifications
Qualifications:

• Bachelor's degree or higher in a relevant scientific or engineering field (e.g., Chemical Engineering, Biomedical Engineering, Biology, Chemistry, or related discipline).
• Previous experience in validation within the life science industry, preferably in pharmaceuticals, biotechnology, or medical devices.
• Strong understanding of validation principles and practices, including knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GMP, GAMP).
• Experience developing and executing validation protocols (IQ, OQ, PQ) for equipment, utilities, facilities, and computerized systems.
• Excellent analytical and problem-solving skills, with the ability to effectively identify and resolve validation-related issues.
• Strong communication skills, with the ability to collaborate effectively with cross-functional teams and communicate validation requirements and findings clearly and concisely.
• Detail-oriented approach with a commitment to ensuring accuracy and compliance in validation documentation and activities.
• Ability to work independently and manage multiple validation projects simultaneously, prioritizing tasks to meet project deadlines.

Preferred Qualifications:

• Certification in validation-related disciplines (e.g., Certified Validation Professional, Certified Quality Auditor).
• Experience with risk-based validation approaches (e.g., ASTM E2500, ICH Q9).
• Familiarity with computerized system validation (CSV) principles and practices.
• Knowledge of statistical analysis techniques and software tools used in validation (e.g., Minitab).
• Experience with validation of process equipment, cleaning processes, or sterile manufacturing systems.
• Familiarity with S4 Hana implementation

What We Offer:

• A career at the forefront of the digital revolution in engineering and manufacturing.
• Opportunities to work with leading-edge technologies and methodologies.
• A collaborative culture that fosters innovation and values diversity.
• Comprehensive benefits package and a commitment to work-life balance.
• Continuous learning and professional development opportunities.

Join us at Accenture Industry X and be a part of the team shaping the future of industry. Apply now to take what you dream and make it real with Industry X.

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