Quality Engineer

Strive Pharmacy•Alachua, FL

2d•$100,000 - $110,000•Onsite

About The Position

The Quality Engineer will partner and collaborate with the QA and Engineering teams to ensure that all required qualifications and validations are performed for the facilities, systems, software and equipment, meeting all partner needs in compliance with standard operating procedures. Specific activities will include review of study design, protocols, execution and reports associated with equipment and process validation studies. Provide review and approval of laboratory method validation and verification. This role will provide technical reviews for Quality risk Assessments, investigations and process evaluations for compounding and laboratory equipment as applicable.

Requirements

Bachelor’s degree in Engineering (Chemical, Electrical or Mechanical) preferred
Minimum of 5 years of experience in facilities, equipment, utilities and FDA regulated environment.

Nice To Haves

PE or EIT, preferred

Responsibilities

Ensure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures.
Develop, review, and approve validation documentation including Validation plans, Protocols (IQ, OQ, PQ), reports and summary documents.
Support lifecycle management of validated systems and software, including requalification, change control, and periodic review.
Provide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9).
Provide quality engineering support to analytical laboratories.
Assist with equipment validation/verification and troubleshooting activities. Support laboratory equipment qualification and lifecycle management.
Lead or participate in cross-functional quality improvement projects.
Drive initiatives related to process optimization, validation efficiency, and quality system improvements.
Support implementation of new technologies, automation, or process changes requiring validation oversight.
Provide technical expertise during new product introduction (NPI) or process transfer activities.
Provide day-to-day quality engineering support to operations.
Support deviation investigations, CAPA development, and root cause analysis.
Participate in change control assessments, ensuring proper validation impact evaluation.
Review and approve technical documentation related to manufacturing and quality systems.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place and maintained.