Senior Quality Engineer

Kindeva•Lexington, KY

1d•Onsite

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. As a Sr. Quality Engineer, 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. This position will provide real‑time quality oversight by monitoring critical operations, auditing documentation for accuracy and compliance, capturing key observations, and proactively escalating quality issues to management.

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

Responsibilities

Support the induction and management of changes of facilities and equipment, including but not limited to: FAT, SAT, URS, etc., for new equipment, facility expansion and commissioning, facility decommissioning, and laboratory or facility movement.
Oversight of New E-system Implementation
Supports the development and maintenance of Quality Systems as appropriate, including leading and supporting manufacturing investigations, change controls, CAPAs, product complaint investigations, and related activities.
Leads continuous improvement objectives to ensure compliance with DEA, FDA, and EMA regulations.
Advises senior management on findings and recommendations related to quality issues.
Reviews and approves cGMP documentation, including procedures, validation protocols, development reports, and other related documents.
Develops and maintains metrics and trending reports for Compliance-related activities.
Performs activities associated with various one-time or ongoing projects.
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
Supports regulatory inspections and customer audits.
Assist the Manager with daily and project activities as needed.