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Validation Engineering Specialist III
1 month ago
As a key member of our team at Thermo Fisher Scientific, you will play a critical role in ensuring the quality and integrity of our products. Your expertise in validation engineering will be instrumental in supporting our operations and clients.
Key Responsibilities:
- Provide leadership to junior validation engineers 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 and provide guidance on 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, and facilities for unique processes and equipment procured in processing, packaging, and PPT areas.
- Attend client meetings as a validation representative (as required).
- Update assigned Master Validation Plans (MVPs) as per validation policy.
- Act as a 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:
Education:
Postsecondary diploma in Engineering, Science, or related field. An Engineering Degree is an asset.
Experience:
Minimum 5 years of experience in validation within the pharmaceutical industry. Previous experience in project management.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
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.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem-solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related fields.
Physical Requirements:
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.
