Senior Quality Systems Engineer II

Kindeva Drug Delivery•Lexington, KY

3d•Onsite

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: As a Sr. Quality Assurance Engineer II, you will play a critical role in ensuring quality oversight and compliance throughout pharmaceutical development and manufacturing operations, with a strong focus on the design, qualification, and implementation of new equipment and systems. By partnering closely with engineering, manufacturing, and external stakeholders, you will help ensure that facilities, utilities, equipment, and electronic systems are introduced and operated in a compliant, efficient, and forward-looking manner. Your expertise in cGMP regulations, validation, and quality systems will directly support regulatory readiness, continuous improvement, and the successful adoption of new and innovative technologies across the site.

Requirements

Bachelor’s degree in a scientific discipline or equivalent years of experience.
At least 5+ years of cGMP experience, with at least 2 years in an engineering or quality assurance role.
Ability to assess problems, to identify solutions, to plan and implement necessary changes
Knowledge of cGMP regulations and validation principles
Ability to work well in a team-oriented environment
Well-developed communication and technical writing skills
Qualified to work with controlled substances
Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus in order to read/understand/execute documentation as required by the position
Employees are required to follow all cGMP and safety procedures.
The employee must wear all required safety equipment and perform assigned work safely.
Employee must use proper lifting techniques and be conscious of hazards around him/her.
Must follow all GMP and safety procedures within the department.
The employee must occasionally lift and/or move up to 20 pounds.

Responsibilities

Provide quality involvement and oversight during pharmaceutical development and manufacturing activities, particularly related to the design, qualification, and commissioning of new equipment and systems.
Support and oversee facility and equipment changes, including activities related to FAT, SAT, URS, commissioning, decommissioning, and facility or laboratory moves.
Provide quality oversight of new electronic system implementations, ensuring compliance with applicable regulatory and data integrity requirements.
Observe critical operations and procedures, audit documentation and records, and communicate quality-related issues and risks to management.
Support the development, maintenance, and execution of Quality Systems, including manufacturing investigations, change controls, CAPAs, and product complaint investigations.
Review and approve cGMP documentation such as procedures, validation protocols, development reports, and related quality records.
Participate in and support compliance assessments (e.g., GxP, Part 11) and regulatory inspections, as well as customer audits.
Develop, maintain, and analyze compliance-related metrics and trending reports to support continuous improvement.
Lead and support continuous improvement initiatives to strengthen compliance with DEA, FDA, and EMA regulations.
Collaborate cross-functionally with internal teams and external suppliers to resolve quality issues and support the implementation of new technologies.
Advise senior management on quality findings, risks, and recommendations.
Support departmental projects and initiatives as assigned.