Develop commissioning and qualification lifecycle documentation. i.e.; IQ, OQ, PQ, FAT, SAT as an example. 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 personnel, Manufacturing, QA, QC, Facilities, Metrology and Engineering departments to assure expeditious and accura... more details
Work Schedule
First Shift (Days)
Environmental Conditions
Office
Job Description
Job Description
Responsible for validation work for projects, as well as participation as an interactive member on Project Teams as a representative of the validation department. Writes and completes commissioning and validation documents for Pharmaceutical Manufacturing Equipment and Systems 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 validation summary reports. Participation on various project teams will be required!
A day in the Life:
Develop commissioning and qualification lifecycle documentation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.
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 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
Bachelor’s degree and 2+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry.
Associate degree and 4+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry.
High school diploma and 8+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry.
Experience
2+ years in validation, pharmaceutical industry
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
Must be proficient on validation protocol development, technical writing, data analysis, and report generation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.
Strong technical writing skills, accuracy, attention to detail, and technical knowledge.
Must be proficient in statistical analysis and process control.
Must have knowledge of process + packaging equipment.
Knowledge of global regulatory and quality requirements associated with medical devices.
Excellent communication skills and an ability to effectively collaborate with others to achieve team goals and expectations.
Self-starter with an ability to work in a fast-paced environment and to effectively manage time and prioritize work.
Experience with pharmaceutical manufacturing equipment and processes
Basic understanding of GMPs
Excellent computer skills (Microsoft Word, Excel, Project, Power Point, etc.)
Thermo Fisher Scientific Inc. is an equal opportunity employer, committed to providing a fair and inclusive workplace for all employees. We believe that diversity drives innovation and success. We also offer reasonable accommodations for individuals with disabilities during the job application process. If you require any accommodations, please contact us at 1-855-471-2255* to discuss your specific needs.
Join us at Thermo Fisher Scientific Inc. and be a part of a team that is dedicated to making a positive impact on the world. Apply today at http://jobs.thermofisher.com.
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