Validation Engineer III

Thermo Fisher Scientific • Frederick, MD

22d • Onsite

About The Position

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 accept 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. Location 4650 New Design Rd Frederick, MD How will you make an impact? As part of our distributed 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 Validation Engineer III, you will be responsible to interact with several departments to provide validation support for computer systems, equipment and processes, along with the critical utilities and facilities required for packaging operations at the site. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. This role requires full-time onsite presence at our Frederick, MD location.

Requirements

• A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science field and 2-5 years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience
• Knowledge of Computer System Validation (CSV)
• Knowledge of Controlled Temperature Unit Operation and Management
• PC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft Word
• Must have strong analytical skills
• Needs to be capable of multitasking and responding to shifting priorities
• Must have good communication skills, both written and verbal
• Must be results oriented
• Must have prior mechanical and process equipment experience

Nice To Haves

• Knowledge of pharmaceutical packaging materials and equipment

Responsibilities

• Responsible for the preparation and execution of validation documentation (VP, IQ, OQ, PQ) as well as the generation of corresponding summary reports
• Position will support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and PPQ.
• Generate, complete, and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment
• Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities.
• Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices)
• Analyze the results of testing and resolve acceptability of results against pre-determined criteria.
• Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them
• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols
• Coordinate with other departments or outside contractors/vendors to complete validation tasks
• Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement
• Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum
• Conducts all activities in a safe and efficient manner
• Other duties may be assigned to meet business needs

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees