Validation Engineer 2

Sectors:
Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Locations:
International
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
14/10/2018
Start Date:
ASAP
Recruiter:
Thermo Fisher Scientific
Job Ref:
535186502

Job Description
Validation Engineer 2 (QA Validation)

When you join us at Thermo Fisher Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
St. Louis, MO

How will you make an impact?

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. Write and execute 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.

What will you do?
* 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. How will you get here?

Education
* Bachelor s degree ibn Engineering, Life Sciences or Computer Science. Experience
* 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. 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. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.

Apply today!

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.

Associated topics: biological engineer, biomaterials, biomechanics, biosynthetic, fermentation, genetic, metabolic, nutrition, pain, parenteral

Closing Date:
11/11/2018
Contact Details:
Thermo Fisher Scientific
Contact: N/A

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