Apex Systems Validation Engineer II in St. Louis, Missouri
Validation Engineer II in St. Louis, MO at APEX Systems
Date Posted: 1/5/2019
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St. Louis, MO
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- Date Posted:
Job Description Job #: 913664
Validation Engineer II (QA Validation)
- This individual is responsible for validation deliverables for projects, as well as participation as an interactive member on Program and/or Project Teams as a representative of the validation department, for a large pharmaceutical company in the Greater St. Louis, MO area.
Responsible for validation deliverables for projects.
Writing and executing, 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.
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.
- Bachelor’s degree ibn Engineering, Life Sciences or Computer Science.
2-5 years of experience in pharmaceutical validation, or equivalent industry experience.
Hands on experience in two or more of the following areas: Validation of computerized systems, software, automation, analytical instruments, utilities, manufacturing equipment, cleaning, sterilization, or general equipment validation.
Pharmaceutical/Biopharmaceutical or related industry background is required.
Experience with change management assessments for validated equipment, systems, and processes.
Required Knowledge, Skills, Abilities
Exposure and knowledge of industry standards and cGMP regulations.
Demonstrated ability to work on multiple projects effectively.
Excellent organizational skills and problem solving abilities.
Proficient computer skills (MS Word, Excel, Project at a minimum). Working knowledge of document management systems and other quality 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 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.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178