Sr Software Systems (QA/Test) Engineer

Major market-leading Pharmaceutical firm needs you for a challenging opportunity as they ramp up for growth via new product launches. Our client has maintained impressive growth and tremendous reputation for over 100 years AND still consistently make Fortune's list of most innovative Companies. They set themselves apart with their commitment to inventing new materials, engineering new technologies and pioneering ways to remain ahead of the competition. Now is the time to set yourself apart from the competition and microwave your career in a unique opportunity at one of the Healthcare industry's most reputable market leaders!

 

As a Sr Validation/ Systems Engineer in the Pharmaceutical industry, you will have the opportunity to build tremendous depth of expertise in manufacturing, GAMP 4/ GAMP 5, PLC and control systems, shop floor monitoring and controls, customer/ product complaints trending and tracking, documentation controls, procedure development and internal/ external auditing via applying QA/Test Strategy in hand-on testing of different applications for planning, designing the testing. Deliver Automation Solutions for Pharmaceutical production that minimize system integration and software validation costs. Deliver competitive Standard Automation Solutions (e.g. GAMP) where required.

 

Efficiently generate high-Quality and highly complex Specification Documents for Process Control Systems with minimal maintenance costs, including integrated auditing and traceability solutions. Global Quality Assurance/ Operations, Qualification/ Validation (Q&V) for facility, equipment and computerized system development, design, implementation, operation and maintenance. Monitoring for regulatory compliance throughout the system life cycle, from development through de-commissioning. Author, review and monitor compliance to Industry standards (e.g. GAMP4, GAMP for Process

 

Control Systems, Six Sigma, ISO, E-Records and E-Signatures, Quality Systems, etc.) into corporate operating principles.

Make significant contributions to the company’s future growth by leading the development, design, implementation and support of quality systems and/or related information systems. Specialize in the development of Quality Management Systems, qualification and validation of computerized systems (e.g. 21 CFR Part 11, GMP, GxP, ISO, GAMP5), regulatory, Risk/ GAP Assessments and remediation, training seminars or workshops, and other activities that focus on corporate or regulatory Quality Assurance (QA) and compliance.

 

System Qualification and Validation of development and design involving Interface technology for Electronic Batch Records (EBR or MES projects), Laboratory Information Systems (LIMS), Laboratory Acquisition Systems (LAS) SAP R2 and R/3 (e.g. ERP, Manufacturing Controls, Sales/ Distribution and Infrastructure/ Basis modules). QA support during audits and/or regulatory inspections with regard to information systems.

 

B.S. degree required, preferably in Computer Science, Mathematics, Software Engineering or some other technical discipline. Must possess strong professional track record in Quality and Compliance activities like Qualification and Validation of Computer Systems, equipment based on GAMP, cGMP, SOx.. e.g. GAMP4, GAMP for Process Control Systems. CFR Part11, GAMP Knowledge, Computer System Validation, Risk based Validation, Design Controls, PRTM’s Product and Cycle time Excellence Framework (PACE). Experience deploying 21 CFR Part 11 regulated systems in the Pharmaceutical Industry. Demonstrated experience in the entire System Development Life Cycle (SDLC). Good knowledge of QA principles, ISO, CMMI and GAMP standards and methodologies. Fluency in FDA CFR 820.30 is preferred.