Quality Engineer

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.

• →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.

This position may also include the following:

• This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects.
• Visual acuity such as: working with data & figures, viewing computer monitor,  extensive reading, operating machinery, general observations of facilities, etc.
• Participation in an occupational health program which can include; medical assessment, surveillance, vaccination, and testing
• Use of personal protective equipment which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.

Exposure to the following:

•  Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
• Working in laboratories & production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled.

The items described here are representative of those that must be met to successfully perform the essential functions of this job.

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

• PE or EIT, preferred

Work Environment: This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities.