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Validation Engineering Specialist III
2 months ago
Job Summary:
We are seeking a highly skilled Validation Engineering Specialist III to join our team at Thermo Fisher Scientific Inc. This role will be responsible for providing specialized validation knowledge and information to support operations and clients.
Key Responsibilities:
- Provide leadership to Validation Engineering Specialist I&II by supporting problem solving and solution generation on projects, training/mentoring, and supporting project progression.
- Prepare and execute process validation protocols and reports.
- Review documents from team members.
- Provide guidance to junior members on various validation requirements.
- Lead complex URS, FS, DS, HS, FAT, SAT document generation, review, and approval.
- Develop and lead project timelines, resources, and budgets for both minor and major projects.
- Review and approve vendor documentation, change controls and maintenance reports.
- Lead risk assessment, HAZOP, FMEA's and Validation plans for Equipment, Systems & Facilities for unique processes and equipment procured in Processing, Packaging & PPT areas.
- Attend client meetings as validation representative (as required).
- Update assigned Master Validation Plans (MVPs) as per validation policy.
- Act as Subject Matter Expert during audit and regulatory inspections. Lead audit responses and assessment.
- Lead/ facilitate technical investigations, deviations, and Corrective Action Preventative Action (CAPA) implementation.
- Lead with a continuous improvement attitude and actively participate in and initiate practical process improvement initiatives.
- Support special projects (as required).
- Maintain a safe working environment and report potential hazards.
- Flexibility to work outside regular work hours (as required).
Requirements:
- Post secondary diploma in Engineering, Science, or related field. Engineering Degree is an asset.
- Minimum 5 years experience in validation within the pharmaceutical industry. Previous experience in project management.
- Equivalent combinations of education, training, and relevant work experience may be considered.
Preferred Qualifications:
- Strong written and oral skills.
- Detail oriented and organized, with a high degree of accuracy and thoroughness.
- Excellent interpersonal skills, communication, and organizational skills.
- Strong judgment, decision making and trouble shooting skills.
- Ability to multi-task, meeting tight deadlines in a fast-paced environment.
- Mini-T and data analysis knowledge an asset.
- Proven computer proficiency with Microsoft Office programs and Project Management tools.
- Proficiency with the English Language.
Working Conditions:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
