Engineer III, Validation

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.

• Responsible for the preparation and execution of validation documentation (VP, IQ, OQ, PQ) as well as the generation of their corresponding summary report
  • This position will also support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and the resulting Process Performance Qualification (PPQ).
• Generate, implement, 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 validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems
• Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies
• Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) activities and protocols
• Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols
• Provide constant communications with all affected departments and personnel regarding validation activities
• Assist with identification and execution of Validation Master Plan (VMP) as required

• Demonstrates and promotes the company vision of the 4 I's: Integrity, Intensity, Innovation and involvement
• Author SOPs related to validation/revalidation activities, as well as, authoring of Validation protocols, within Documentum

• Conducts all activities in a safe and efficient manner

• Other duties may be assigned to meet business needs

• A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 2+ 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 Controlled Temperature Unit Operation and Management
• PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word
• Must have strong interpersonal skills
• Must have strong analytical skills
• Must be able to multitask and respond to shifting priorities
• Must have good communication skills, both written and verbal
• Must be results oriented
• Must have prior mechanical and process equipment experience

• Proficient with Mini-Tab or similar statistical analysis software
• Knowledge of pharmaceutical packaging materials and packaging equipment

• Must be able to lift 35 pounds