Senior Quality Engineer

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.

• 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.

• 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 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.
• Employees 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.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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