Staff Engineer - Software Quality - Indianola, Pa (Hybrid)

Bayer•Indianola, PA

56d•Hybrid

About The Position

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Staff Engineer - Software Quality - Indianola, Pa (Hybrid) Staff Engineer - Software Quality - Indianola, Pa (Hybrid) PURPOSE This position has responsibility for performing activities that support and maintain an effective software quality assurance system and will have responsibility for medium to high complexity projects. Specifically, this position will provide quality oversight for software that is used as part of the quality system including software used in the manufacturing and R&D processes. This position will champion departmental and/or cross-functional initiatives by leading and supporting implementation of large complexity projects to meet Bayer goals and priorities. This is a hybrid position 50% onsite presence is required.

Requirements

Bachelor's Degree
6 - 10 Years' experience in regulated industry
Basic knowledge of other technical disciplines
Ability to work collaboratively with other departments
Strong communication and interpersonal skills
Ability to work well in high pressure environment and manage multiple concurrent projects
Proven ability to demonstrate technical writing skills
Knowledge of FDA QSR and ISO Quality and process validation standards

Nice To Haves

Bachelor's degree in Engineering or IT
Master's degree
Computer System Validation experience
GAMP experience
Direct experience in medical device industry

Responsibilities

Provides Quality Assurance oversight for the validation of quality system software, including manufacturing and R&D process software for Radiology, for the Indianola, O'Hara and Saxonburg sites;
Engages with project teams to ensure compliance with internal and external requirements for validation of quality system software. This includes compliance with requirements for data integrity, CFR Part 820, FDA Guidance for Industry on Process Validation and CFR Part 11;
Ensures that appropriate, risk-based principles for software validation are utilized;
Provides Quality Assurance oversight for changes to quality system software;
Maintains the computerized software list to ensure that it contains the current quality system software validation information;
Manages the process to monitor compliance for periodic validation and audit trail reviews. Periodically reports on status of recurring reviews;
Creates and maintains SOPs, work instructions, forms, templates, and performs required gap assessment;
Leads/supports quality system improvement projects.