Serves as subject matter expert for the validation department. Responsible for validation deliverables for projects, as well as participation as an interactive member on Project Teams as a representative of the validation department. Writes and executes commissioning and validation documents for equipment, instruments, facilities, utilities, processes (cleaning and sterilization) and computer systems, utilizing the lifecycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports. Participation on various project teams will be required.
- Develop commissioning and qualification lifecycle documentation.
- Author and/or revise SOPs as necessary.
- Advise functional departments on the creation of user and system specifications and requirements, as well as reviewing/approving these documents.
- Responsible for protocol execution requiring interface and coordination with Validation Contractor personnel, Manufacturing, QA, QC, Facilities, Metrology and Engineering departments to assure expeditious and accurate completion per agreed upon project plan.
- Summarize and evaluate protocol data, including resolution of discrepancies and exceptions as required for completion of validation summary reports.
- Perform periodic reviews or re-qualifications to maintain validation status of equipment, instruments, facilities, utilities and computer systems as defined by approved validation SOPs.
EDUCATION AND QUALIFICATIONS:
- Bachelor Degree in Engineering, Life Sciences or Computer Science
- 8+ years of experience in pharmaceutical validation, or equivalent industry experience.
- Subject matter expert in one or more of the following areas: Validation of computerized systems, software, automation, analytical instruments, utilities, manufacturing equipment, cleaning, sterilization, or general equipment validation.
- In depth knowledge of industry standards including 21CFR Part 11.
- In depth knowledge of cGMP regulations.
- Demonstrated ability to work on multiple projects effectively.
- Excellent organizational skills and problem solving abilities.
- Proficiency in computer system validation is preferred, including, but not limited to, standalone systems, open/closed systems, client/server based systems, PLC based systems, data backup/archiving strategies, disaster recovery, and configuration management.
- Experience with change management assessments for validated equipment, systems, and processes.
- Proficient with computer (MS Word, Excel, Project at a minimum). Working knowledge of controlled documentation and data systems.
- Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make logical decisions based on guidance from management.
- Able to aseptically gown and/or sterile gown as needed
- Able to work within environmental clean rooms
- Able to function in a rapidly changing environment and balance multiple priorities simultaneously
- Able to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Regularly required to talk and hear. The employee frequently is required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.