ENGINEER QUALITY

CAPA and Investigations)

Position Title : Engineer Quality

Department : Quality

FLSA Status :

Reports To : Director Quality

Prepared By : HR / Department Manager

Revised Date : 06 / 08 / 2022

Summary :

The primary role of the Engineer Quality is to develop documentation and investigate facility systems and processes to ensure compliance with FDA regulations.

Develop and monitor change control processes, variances and investigations for continuous process control. Responsible for maintaining Process Variance Reports and Annual Product Reviews for the St.

Louis locations. Ensure budget and schedule remain complaint with contract and department needs.

Essential Duties and Responsibilities :

• Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day.
• Present for work when scheduled is a mandatory function.
• Your compliance and enforcement of all company safety rules procedures and guidelines is essential. Reporting of safety issues is mandatory.
• Assist in the maintenance of the Validation Master Plans
• Coordinate resources and communicate project progress, applying project management tools and techniques effectively for multiple projects
• Ensure GMP required documentation is following governmental regulations such as FDC.
• Monitor and interpret the Federal Register and other sources that provide information on laws pertaining to Food, Drugs and Cosmetic Industries.

Advise and inform management on validation issues.

• Define and / or improve upon systems and processes
• Maintain quality system of Process Variance Reports (PVR)
• Generate Annual Product Reviews (APR)
• Read and understand Piping and Instrumental Diagrams and create Process Flow Diagrams.
• Develop or assist with process control procedures and automation specifications, where necessary, to ensure on-going compliance.
• Evaluate data from current processes to recommend improvements, cost effectiveness and production quality.
• Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done;

must respond timely to deliver quality investigations and thorough CAPAs

• Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) Studies to assess system and processes.
• Assist in GMP and GDP training of new personnel.
• Create or modify SOPs and work instructions. Recommend changes to batching instructions.
• Perform Statistical Process Analysis to evaluate process control.
• Perform Site Acceptance Tests and Factory Acceptance Tests prior to equipment startup, as required.
• Review final validation protocols for facilities systems (IQ / OQ / PQ), processes (PV), and cleaning validations (CV)
• Perform all other duties as assigned.
• Supervisory Responsibilities N / A
• Education Requirements :

Bachelor’s Degree required in a related Science or Engineering field. Knowledge of current GMPs and other FDA regulations and the ability to develop technical complaint documents is required in this position.

Requires excellent oral and written communication skills. Ability to handle stress and work with multiple priorities. Proficient in Microsoft Office products.

Experience Requirements :

A minimum of two to five (2-5) years’ experience in manufacturing of food, cosmetics or pharmaceutical products required.

Experience with filtration, water pretreatment and reverse osmosis water systems; CIP / SIP systems and processes; steam, cooling water, batch mixing, sanitary piping systems;

understanding of PLC functions preferred. PLC Programming knowledge is preferred. Ability to troubleshoot process and utility equipment required.

• Certificates, Licenses, Registrations :
• N / A
• Travel :
• None

Work Environment :

Exposure to normal office environment as well as warehouse and production floor. Will be exposed to ambient noise level in a manufacturing environment.

When in the manufacturing environment, worker exposed to heat and cold with temperatures sufficiently high or low to cause discomfort.

Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

Physical Demands :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand;

walk; use hands to finger, handle or feel; and reach with hands and arms.

Summary :

The primary role of the Engineer Quality is to develop documentation and investigate facility systems and processes to ensure compliance with FDA regulations.

Develop and monitor change control processes, variances and investigations for continuous process control. Responsible for maintaining Process Variance Reports and Annual Product Reviews for the St.

Louis locations. Ensure budget and schedule remain complaint with contract and department needs.

Essential Duties and Responsibilities :

• Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day.
• Present for work when scheduled is a mandatory function.
• Your compliance and enforcement of all company safety rules procedures and guidelines is essential. Reporting of safety issues is mandatory.
• Assist in the maintenance of the Validation Master Plans
• Coordinate resources and communicate project progress, applying project management tools and techniques effectively for multiple projects
• Ensure GMP required documentation is following governmental regulations such as FDC.
• Monitor and interpret the Federal Register and other sources that provide information on laws pertaining to Food, Drugs and Cosmetic Industries.

Advise and inform management on validation issues.

• Define and / or improve upon systems and processes
• Maintain quality system of Process Variance Reports (PVR)
• Generate Annual Product Reviews (APR)
• Read and understand Piping and Instrumental Diagrams and create Process Flow Diagrams.
• Develop or assist with process control procedures and automation specifications, where necessary, to ensure on-going compliance.
• Evaluate data from current processes to recommend improvements, cost effectiveness and production quality.
• Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done;

must respond timely to deliver quality investigations and thorough CAPAs

• Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) Studies to assess system and processes.
• Assist in GMP and GDP training of new personnel.
• Create or modify SOPs and work instructions. Recommend changes to batching instructions.
• Perform Statistical Process Analysis to evaluate process control.
• Perform Site Acceptance Tests and Factory Acceptance Tests prior to equipment startup, as required.
• Review final validation protocols for facilities systems (IQ / OQ / PQ), processes (PV), and cleaning validations (CV)
• Perform all other duties as assigned.
• Supervisory Responsibilities N / A
• Education Requirements :

Bachelor’s Degree required in a related Science or Engineering field. Knowledge of current GMPs and other FDA regulations and the ability to develop technical complaint documents is required in this position.

Requires excellent oral and written communication skills. Ability to handle stress and work with multiple priorities. Proficient in Microsoft Office products.

Experience Requirements :

A minimum of two to five (2-5) years’ experience in manufacturing of food, cosmetics or pharmaceutical products required.

Experience with filtration, water pretreatment and reverse osmosis water systems; CIP / SIP systems and processes; steam, cooling water, batch mixing, sanitary piping systems;

understanding of PLC functions preferred. PLC Programming knowledge is preferred. Ability to troubleshoot process and utility equipment required.

• Certificates, Licenses, Registrations :
• N / A
• Travel :
• None

Work Environment :

Exposure to normal office environment as well as warehouse and production floor. Will be exposed to ambient noise level in a manufacturing environment.

When in the manufacturing environment, worker exposed to heat and cold with temperatures sufficiently high or low to cause discomfort.

Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

Physical Demands :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand;

walk; use hands to finger, handle or feel; and reach with hands and arms.