Job Information
ThermoFisher Scientific Engineer II, Validation in Middletown, Virginia
Work Schedule
First Shift (Days)
Environmental Conditions
Office
Job Description
Engineer II, Validation
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.
Required Qualifications:
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.
Preferred Qualifications:
- 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.)
Work Conditions:
Normal office environment. Position will require sitting and standing.
Employee may occasionally lift and/or move up to 10 pounds.
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.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.