Sr. Validation Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

When you are part of the team at Thermo Fisher, you’ll do important work, like helping

customers in finding cures for cancer, protecting the environment, or making sure our food is

safe. Your work will have real-world impact, and you’ll be supported in achieving your career

goals.

Location/Division Specific Information

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3,500 employees in over 15 countries work hard every day knowing that what they do matters.

How will you make an impact?

As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.

What will you do?   

As a Senior Validation Engineer, you will coordinate with several departments to provide validation support to validate computer systems, equipment, processes, critical utilities and facilities required for packaging operations at the site. You will be responsible to ensure site compliance and all vital activities are performed on time to keep all GxP systems in a validated state.

Responsibilities:

• Lead and further develop the Validation and Technical Services Department!

• Responsible for the preparation, execution, and eventual review and approval, of documentation (SIA, URS, RA, FAT, SAT, VP, IQ, OQ, PQ, TM, PPQ) as well as the generation of corresponding summary report

• Achieve and maintain a level of Validation expertise for all systems and processes at the site in order to coach and mentor junior validation engineers

• Continuously look for means to optimize processes to improve compliance and efficiency.

• Lead meetings and participate in other discussion to obtain agreement on Validation approaches

• Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices).

• Prepare, maintain, or review validation and compliance documentation, such as engineering change controls, schematics, or protocols

• Coordinate Validation Projects and ensure project timelines

• Drive maintenance of the Validation Master Plan (VMP) as needed

• Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement

• Author SOPs related to validation/revalidation activities

• Demonstrate sound decision making related to priorities

• Conducts all activities in a safe and efficient manner

• Other duties may be assigned to meet business needs

REQUIREMENTS:

• A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 5 years of validation experience in a regulated industry

• Experience with regulatory requirements as applied to the qualification and management of Controlled Temperature Unit (CTU) Operation

• Knowledge of the lifecycle of Validation documentation is required

• PC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft Word

• Must be prepared to provide direction and leadership to team and external functions and activities

• Must exhibit Interpersonal skills; analytical skills; ability with multitasking/shifting priorities

• Must be results oriented

Desired Qualifications:

• Proficient with Mini-Tab or similar statistical analysis software

• Knowledge of pharmaceutical packaging materials and packaging equipment

Physical Requirements

Must be able to lift 35 pounds