Validation Engineer III
Share
Job Location:
Allentown, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.)Job Description
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 3500 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 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 tasked with interacting 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.
Accountable for preparing and carrying out validation documentation (VP IQ OQ PQ) along with producing the related summary reports
Give to the preparation of Process Performance Qualification (PPQ) documentation which includes 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.
Work closely with engineering to coordinate and complete Factory Acceptance Testing (FAT) activities and protocols.
Prepare detailed reports or build 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 Assist with identification of Master Plan (VMP) as required Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum Conduct all activities in a safe and efficient manner
Knowledge Skills Abilities
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
Effective communication skills
Strong analytical skills
Ability to multitask and respond to shifting priorities
Effective written and verbal interaction abilities
Prior mechanical and process equipment experience
Desired Qualifications
Proficient with Mini-Tab or similar statistical analysis software
Knowledge of pharmaceutical packaging materials and equipment
Education
- A four-year Bachelor of Science degree in Engineering or Science from an accredited college is required.
- You must have 2-5 years of validation experience in a regulated industry or equivalent experience. This includes five years in food or pharmaceutical packaging or cGMP experience.
Physical Requirements
- Needs to be capable of lifting 35 pounds
Benefits
We offer competitive remuneration annual incentive plan bonus scheme healthcare and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
