Sr. Validation Engineer

Sunrise Systems was founded in 1990 with a vision to deliver world class staffing services and solutions in all categories, including leading edge IT consulting and solutions, with the commitment to deliver service that exceeds expectations and become the most trusted name in the industry. Today, two and a half decades later, we pride ourselves on being the forerunner in the staffing and Information Technology business. We combine our deep industry expertise, insight and global resources to build the best workforce for our clients and by connecting them with the perfect professionals across different industry verticals.

Summary:

• Responsible for but not limited to, working under operations engineering department in developing and executing process and equipment validation protocols, as applicable to ensure compliance to applicable regulatory requirements, internal company standards and industry practices.

• As a member of Operation team, responsible for developing /supporting of revenue and process improvement projects and executing IQ/OQ/PQ protocols including temperature mapping for storage equipment and facilities, as applicable, and making recommendations for changes and/or improvements.

• Ensure project completion per schedule, overall compliance and continuous quality and product/process improvement in an ever-changing, regulated environment.

• Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities and incumbent(s) may be required to perform additional, position-specific tasks.

• Develop and execute validation protocols (IQ/OQ/PQ/PPQ/PV) and test scripts for all applicable equipment, systems, products and processes, temperature mapping, including required annual re-qualifications and writing final validation reports.

• Work with the Sr. Validation Engineer / Manager for Validation services and other Operation Engineering and Quality Management in the development of Validation Plans, Documents & Reports/Records.

• Develop and perform engineering studies for improvements of equipment performance or process capabilities to reduce costs and cycles with ensuring validations.

• Assess effectiveness via auditing and validations of systems with respect to all relevant guidance, regulations, standards and requirements.

• Work with Manager of Validation services to ensure consistency of systems/practices across product lines and their conformance to regulations and other industry practices and identify area of continuous improvement.

• Technical writing of Quality, Equipment and Processing Operating Procedures (SOP), Component Specifications and other documentation, as required.

• Maintain a thorough knowledge and understanding of the following regulations and guidelines: FDA 21 CFR 1270 and 1271 – Current Good Tissue Practices, American Association of Tissue banks for Tissue banking, 21 CFR 820 - Medical Devices - Quality System Regulations, ISO 9001 – Quality Management Standards, ISO 9001 Quality Management System Standards, ISO 13485 - Medical Device – Quality Management System, ISO Clean Room Standards and others as required.

• Partner and practice in the Operation Engineering, Manufacturing and Quality along with Quality Planning process for LifeCell’s Quality Management System and support the entire manufacturing/operations and quality effort at LifeCell.

• Develop and / or Revise manufacturing and engineering documentation, ensuring compliance between manufacturing process documentation, all applicable specifications, and engineering drawings while providing required operator training.

• Experience in managing Quality Investigation (QI and Corrective and Preventative Actions (CAPA) and collaborating with quality and manufacturing in the root cause verification and corrective action implementation.

• Lead and effectively interface with Manufacturing/Production, Maintenance, Quality, external vendors, and other support teams to complete projects meeting with production, quality, cost savings, and new product / process development goals within schedule and budget.

University Degree:

• BS in Engineering or other sciences. Higher degree will be a plus.

• Experience: 5 to 7 years of experience in validation and quality related field.

Other Required Skills:

• Proficiency in Microsoft office tools (Excel, Word, Power Point, Access, Project), Track Wise and Oracle Use.

• Use of statistics techniques for sampling plan will be a plus.

• Grasps concepts quickly especially related to Federal, AATB, ISO and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA 21 CFR 1270 and 820, ISO 13485 and others as required.

• Self-starter with excellent technical writing, analytical and interpersonal skills to allow effective participation in project teams and project execution.

All your information will be kept confidential according to EEO guidelines.