USA-Quality Manager III (Engineering)

TalentBurst•Swiftwater, PA

10d•Onsite

About The Position

The Quality Validation Engineer / Validation Specialist role is a 12-month contract position located in Swiftwater, PA. This role requires 6-9 years of experience in regulated manufacturing environments, with a strong focus on quality validation, quality systems, and regulatory compliance. The ideal candidate will have a Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, with a Master's degree being preferred. Responsibilities include leading and managing CAPA investigations, supporting various validation activities, and collaborating with cross-functional teams.

Requirements

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
Proven ability to collaborate effectively with cross-functional teams.
Strong analytical and problem-solving skills with exceptional attention to detail.
Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
Excellent verbal and written communication skills.
Self-motivated, organized, and capable of working independently.

Nice To Haves

Master's degree preferred.
Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.

Responsibilities

Lead and manage Corrective and Preventive Action (CAPA) investigations and activities.
Support validation activities, including equipment, process, facility, computerized systems, and documentation review.
Collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
Manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
Present complex information clearly to diverse stakeholders.
Work independently in a fast-paced, regulated environment.