Software Engineer II

This position uses industry best practice and quality engineering principles to create and enforce a rigorous software validation program as part of overall product quality architecture commensurate to ever-evolving customer and business needs. This includes, but is not limited to, all stages of product Innovation (& Design/Development Controls) and business/manufacturing/quality software system implementation.



This position works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement and Business Operations) to develop and implement a standardized, lean, compliant approach to verifying software meets or exceeds internal/external customer and regulatory expectations.



DESCRIPTION OF WORK:

Standardization and streamlining of validation processes across life science division(s) to assure conforming, compliant software is made available to internal/external customers in a timely manner

Coordinate with various functional groups to ensure understanding, documentation, and verification/validation of software requirements

Self-initiative for continuous improvement within the organization

Act as Quality representative on projects of varying scale and complexity

Champion and proponent of software IQ/OQ/PQ validation systems within the organization as SME, Trainer, and Coach

Apply best quality engineering practices and guidance to support project teams in software user requirement creation and verification/validation

Serve as a resource for performing internal audits to ensure quality system compliance.

Create technical documentation that fits business needs and maintains compliance to applicable international standard and regulatory requirements (e.g. ISO, FDA, EU, etc.)



EXPERIENCE:

Required:

BS degree in a field relevant to the position (Bachelors Minimum Required)

5+ years of pharmaceutical, medical device, and/or biotechnology industry manufacturing and product software quality engineering and/or assurance experience.



Preferred:

Product application knowledge and experience.



MINIMUM QUALIFICATIONS:

Background in 21 CFR Part 11-compliant software validations, including systems such as inspection systems, vision systems, manufacturing execution systems, and material handling systems

Knowledge of applicable industry standards, regulations, and requirements (e.g. GAMP, medical device and pharmaceutical GMPs, ISO 9001, ISO 13485, Quality Systems Regulations 21 CFR part 820)

Familiarity and working knowledge of manufacturing and business software for data collection, data storage and analysis, project management, statistics, word processing, reporting, communication, manufacturing execution and other operational management systems, laboratory information systems, and programmable logic controllers.

Advanced working knowledge of Microsoft Office applications

Ability to communicate and work with all levels and functions within the organization

Ability to influence others with objective insight and best practices

Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.

Ability to influence individuals without authority and to motivate others within a project team.

Ability to make objective decisions regarding software suitability and conformance.

Must be action-oriented, make informed decisions, be self-motivated, capable of influencing without authority.

Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.

Flexibility to assume ownership on projects and coordinate the efforts of others to complete project goals or participate on a team to support other project leads; must also possess the ability to effectively manage conflict.

Knowledge of manufacturing processes and relevant software quality assurance practices

Thorough understanding of validation in the context of integrated software systems.

Ability to react to change and perform other duties as assigned.