Staff Validation Engineer

Job Title: Validation Staff Engineer
Reports To: Sr. Manager, Manufacturing Engineering
Career Band: 07
Group/Division: SDG/CDD
Job Track: Professional
Job Family: Operations
Job Sub-Family: Validation
Job Code: QVAL
Location: Middletown, Virginia
No. of Direct Reports: 0
Day/Shift: 1st Shift
FLSA Status: Exempt
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
The Validation Staff Engineer is responsible for leading / assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new product development, and working as part of a cross-functional team responsible for sustaining change.
The Validation Staff Engineer is an active participant in the origination of design concepts and specifications, process/technology development, product verification/validation, project planning, and other applicable documentation while adhering to quality and manufacturing requirements.

JOB DESCRIPTION:

• Serve as the primary interface between Operations and Quality Assurance.
• Originate and assist in the preparation and approval of change orders related to the operation and improvement of manufacturing processes.
• Assist the validation team in maintaining the Site Validation Master Plan.
• Support development projects, transfer projects, process changes, and engineering projects to provide overall guidance as it relates to quality standards, inspection techniques and frequencies, statistical analysis, testing, validations, and risk assessments (FMEAs).
• Direct and oversee validation activities for Operations, Engineering, Quality Assurance, and other functional areas.
• Review, revise, and maintain site validation procedures, qualification protocols, and associated data in accordance with FDA and ISO requirements.
• Lead and/or assist in training of staff involved in validation activities.
• Assist Quality, Operations, and Engineering personnel during inspections or audits.
• Performs other duties as assigned by Staff Validation Engineer and direct manager.

MINIMUM EDUCATIONAL REQUIREMENTS/QUALIFICATIONS:

• Bachelor’s degree from a four-year college or university and 10+ years of relevant experience or in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities is required.
• Associate degree and 15+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities is required.
• Knowledge of global regulatory and quality requirements associated with medical devices.
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• Experience with formal problem solving in a team environment.
• Detail oriented with the ability to lead multiple projects and activities as assigned.
• Proficiency in Microsoft Office products (i.e. Mini Tab, Excel, Outlook, PowerPoint, etc.).
• Previous medical device (Class II or Class III) experience required (from product development, Validation Engineering, sustaining engineering or manufacturing engineering).
• Must have good oral and written communication skills. This includes interfacing with external customers and internal Senior Management.

PHYSICAL REQUIREMENTS:

• Normal office and manufacturing environment.
• Position may require frequent communication and walking to other areas in which designated PPE will be required.
• Position will require sitting and standing.
• Employee may occasionally lift and/or move up to 25 pounds.

Please refer the Job description for details