Validation Engineer - Golden, Colorado, United States
8 hours ago
Job description
Role and Responsibilities
This position is responsible for managing, inspecting, testing, and modifying the instrumentation, equipment, mechanics, and procedures used to manufacture products in accordance with all company Standard Operating Procedures and manufacturing instructions, and to ensure all systems and processes are running correctly and efficiently to produce high quality products. This position is also responsible for investigating equipment and processes to ensure they meet FDA and USP compliance standards. This position reports to the Quality Manager and Operations Manager.
Responsibilities include:
Consult and cooperate with appropriate departments and staff regarding scheduling of testing, qualifications, and project implementation.
Prepare protocols, reports, and other necessary documentation for validation to determine whether systems and processes meet required criteria and specifications.
Identify root causes of production or equipment problems.
Evaluate current equipment and procedures used in production to certify operations are within regulations.
Ensures equipment and processes responsible for manufacturing and/or packaging products in a manner which aligns to cGMPs (Good Manufacturing Practices), GLPs (Good Laboratory Practices) and Safety Standards.
Establish validation standards, develop testing protocols, prepare equipment, document test results and analyze results to ultimately determine if a new process or new equipment meets policies and standards.
Communicate with outside vendors to identify new equipment or perform equipment troubleshooting if problems arise.
Investigate the causes of equipment failures and anomalies and decide if the equipment needs to be repaired or replaced. Modify test methods or revisit test objectives to resolve equipment/process testing if needed.
Maintain validation documentation through the validation lifecycle
Represent the engineering process during regulatory audits (internal and external)
Perform other regulated duties as assigned.
Able to perform duties of the Manufacturing Technician
Ensure that product is manufacturing according to established specifications, Standard Operating Procedures and manufacturing instructions, which includes visually monitoring product, performing in-process product sampling/testing and analyzing samples for quality.
Independently sets-up, operate, cleans, and maintains manufacturing equipment.
Completes production records according to specifications.
Responsible for following GMP's/GLP's, safety rules and regulations.
Follows Batch Production Records, Maintenance Manuals, various forms, logs and can comprehend and complete the various manufacturing paperwork required for batch record processing, including labels, log books, production batch records, maintenance and calibration.
Can perform simple math calculations required for batch processing, such as determining loss amounts, process yields and accountabilities and reconciliations.
Cleans tools, supplies, equipment, production processing rooms, storage rooms and general areas in accordance with Standard Operating Procedures.
Responsible for maintaining personal training qualifications.
Required to wear personal protective equipment when necessary.
Qualifications and Education Requirements
REQUIRED: Bachelor's degree in Engineering (Chemical, Mechanical, Manufacturing, Electrical, or Software).
Required: 3-5 years of experience and/or knowledge of pharmaceutical and/or laboratory processes, systems, equipment, and applicable government regulations.
Mechanical aptitude required. Possess critical thinking skills to troubleshoot and commission equipment/processes.
Thorough understanding of applicable mathematics and scientific practices.
Proficient in Microsoft Word and Excel.
Possess excellent communication skills, both oral and written. Ability to work as part of a team and provide leadership where needed.
Ability to resolve conflicts and provide solutions
Must be able to read, understand and follow GMPs, SOPs, Specs, and all guidelines as they relate to the process
Possess time management skills and the ability to manage oneself. Projects must be completed in a timely manner and per the testing timelines
Superior attention to detail
Experience in technical writing.
Preferred Skills
Experience with centrifuges, hoods, HPLC's, incubators, autoclave, depyrogenation ovens, freezers, Kaye Validator
Additional Notes
Must be able to lift up to 50 lbs. frequently throughout the day
Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
Must be able to wear required PPE for long periods of time when required.
Position requires handling of laboratory chemicals or hazardous materials
Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned.
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