Validation Engineering Specialist II – Equipment Engineering

Job summary

The Validation Engineering Specialist will lead equipment commissioning and qualification activities while developing validation strategies for systems and facilities. They are responsible for preparing validation protocols, reports, and risk assessments to ensure compliance with GMP and client requirements.

Job details

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Summary: Provide specialized validation knowledge and information, which is directly required to support operations and clients. Complete all protocols related to the validation of equipment, facilities processes and new products and review all finished reports prior to final approval. Ensure documents conform to all Patheon Standard Operating Procedures (SOPs), client requirements and Good Manufacturing Practices. Essential Functions: Develop validation C&Q strategies for Equipment, Systems & Facilities. Supporting Processing, Packaging & PPT areas. Lead equipment commissioning and qualification activities and support project manager. Develop and manage project timelines, resources and budgets for both minor and major projects. Prepare Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for complex equipment, facilities, and computer systems. Prepare validation protocols and reports independently, including preparation of additional studies, rationales to support TRO operations. Review and approve vendor documentation. Prepare risk assessment, HAZOP, FMEA’s and Validation plans for Equipment, Systems & Facilities, for Processing, Packaging & PPT areas. Conduct technical discussions and present strategies and outcomes with clients, project managers and other stakeholders to drive validation activities. Contribute to generation of URS documents. Support/manage compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs) for the Equipment Engineering department. Support audit preparation, assessments and participate in audits to ensure adherence to regulatory standards. Maintain a continuous improvement mindset and actively participate in and initiate practical process improvement initiatives. Maintain a safe working environment and report potential hazards. Flexible to work extended hours or off-shifts based on project expectations (as required). REQUIRED QUALIFICATIONS Education: Post secondary diploma in Engineering, Science, or related field. Engineering Degree is an asset. Experience: Minimum 3 years' experience in validation, process engineering or quality within the pharmaceutical/ biotechnological industry. 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. Demonstrated 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, modelling 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 field. 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. Disclaimer: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. Compensation The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.

What you’ll do

The Validation Engineering Specialist will lead equipment commissioning and qualification activities while developing validation strategies for systems and facilities. They are responsible for preparing validation protocols, reports, and risk assessments to ensure compliance with GMP and client requirements.

Requirements

Candidates must possess a post-secondary diploma in Engineering or Science, with an Engineering degree considered an asset. A minimum of 3 years of experience in validation, process engineering, or quality within the pharmaceutical or biotechnological industry is required.

Listed skills

• Continuous Improvement · Preferred
• Validation · Preferred
• Quality assurance · Preferred
• Regulatory Compliance · Preferred
• Data analysis · Preferred
• Communication · Preferred
• Troubleshooting · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Validation
• Process Engineering
• Quality Assurance
• GMP
• Commissioning
• Qualification
• Risk Assessment
• HAZOP
• FMEA
• Project Management
• Technical Writing
• Regulatory Compliance
• Continuous Improvement
• Data Analysis
• Troubleshooting
• Communication
• Qualification Protocols (IQ/OQ/PQ)
• Workflow Management
• Organizational Skills
• Validation Protocols
• Equipment Engineering
• Budgeting
• Auditing
• Management
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Decision Making
• Continuous Improvement Process
• English Language
• Packaging And Labeling
• Failure Mode And Effects Analysis
• Standard Operating Procedure
• Hazard And Operability Study
• Interpersonal Communications
• Problem Solving
• Key Performance Indicators (KPIs)
• Microsoft Office
• Motor Coordination
• Multitasking
• Operations
• Personal Protective Equipment
• Pharmaceuticals
• Safety Standards
• Risk Analysis
• Timelines
• Visual Acuity
• Scheduling
• Process Improvement
• Environment Health And Safety
• Disaster Recovery Solution

Job areas

• Engineering
• Manufacturing
• Healthcare
• Science & Research
• Equipment Engineering Manager
• Validation Specialist
• Process Control Technicians Not Elsewhere Classified
• Validation Engineers
• Industrial Engineers