·       Coordinates validation efforts for computer systems, hardware, and software, especially within a manufacturing setting, to ensure product quality.

·       Support computer validation projects by creating computer system validation documents and testing protocols, reviewing test results, assist in completion of compliance assessments (DI and audit trail), and identifying areas to implement change for improvement.

·       Provide technical expertise to internal customers and the validation department while communicating the validation plan and creating protocols to ensure product complies with Current Good Manufacturing Practice (cGMP), Good Automated Manufacturing Practice (GAMP), and 21CFR.

·       Independently work with complex issues related to day-to-day activities and escalate issues when necessary.

·       Actively participate within DP and others to analyze and address process deficiencies. 

·       Work collaboratively with others in the Validation, Manufacturing, Manufacturing Engineering and QA groups.

·       Requires a Bachelor degree with at least 2+ years of experience; OR Associate degree with at least 3 to 5 years’ experience working in the pharmaceutical industry or industry regulated by GMP standards and requirements.

·       A minimum of 1 year of relevant experience in the biopharmaceutical industry or its equivalent including a knowledge of cGMP, GAMP, and 21CFR Part 11 guidelines for computer system (hardware, application software and operating system)

·       Proactive, self-starter with good decision-making skills and capable of working alone or in a team environment to develop automation protocols and collect data to draw valid conclusions.

·       Experience in Computer/Software validation (prepare IQ, OQ, PQ protocol, execute and prepare final summary report) and an understanding of deviation and change management for plant manufacturing equipment software. 

·       Strong proficiency of written and verbal communication skills with ability to effectively collaborate with technical and senior management staff.

·       Ability to work effectively under pressure, handle multiple projects, and meet deadlines.

·       Familiar with Microsoft Office suite of applications

·       Previous DCS (DeltaV), SIEMENS and Rockwell automation systems testing experience is preferred.

·       Experience in data governance, data integrity (DI) assessment, audit trail review, security, user access review, trace matrices, etc. is preferred. 

·       Ability to develop and apply new and innovative approaches to projects and processes; a working understanding of lean principles and establishment of effective process metrics is preferred.

·       Adhere to QA policies and procedures (SOPs), training materials and tools to ensure DP meets quality standards and regulatory requirements. 

Education/Experience/Licenses/Certifications

·       Bachelor of Science in Engineering, Computer Science, or equivalent technical degree or equivalent applicable experience.

·       Experience and understanding of 21 CFR Part 11, GAMP compliance for computer system (hardware, application software and operating system).

Physical Demands:

This is an office-based position which requires appropriate levels of personal protective equipment (PPE) when field work is require. 
Frequent repeated motions such as keyboarding is required.

Work Environment

This position is based indoors, and the employee will primarily be working with others, but also independently.  It requires the employee presence to be on-site 50-100% of the time.  This a team and project-based position that may require occasional shift work, weekends, and holidays.

Travel:

This position may require up to 10% of travel.