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Process Validation Engineer

3 months ago

North York, Canada TalentBurst, an Inc 5000 company Full time

Title: Validation Engineer III (Engineering)

Location: Toronto, ON

Duration: 12 Months


Position Summary:

This position is responsible for ensuring that all aspects of Process Validation activities for the B200 project, including Process Design, Process Engineering Batches, Process Development Batches, PPQ Batches are executed on time and in accordance with the Validation Master Plan, local and global requirements, and applicable regulations. In addition, this position will be responsible for developing a process for Continuous Process Verification post completion of PPQ batches. This role is also expected to support the Deputy Director (Commissioning Qualification Validation) during the commissioning & qualification phase.

As an integral part of the project quality team, this position has overall accountability for leading/participating in project workstreams, ensuring proper execution of process validation strategies as well as providing support and guidance for quality processes and procedures.

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices.


Key Responsibilities:

Responsible for managing C&Q and process related validation activities related to Flu Manufacturing Process.

Oversee all aspects of project validation activities in accordance with the Validation Master Plan and project deliverables,

including but not limited to:

• Participate in Design and execution of Cleaning Validation Activities.

• Engineering, Development and PPQ Batches.

• Application of risk analysis and risk analysis tools.

• Develop on-going monitoring program.

Act as the accountable Subject Matter Expert (SME) for the project on all matters related to Flu Manufacturing Process.

Actively leads and/or engages in project work stream meetings, planning and scheduling meetings, and any related project

requirements to ensure effective planning and execution of key Process Validation deliverables.

Maintain and report on key project deliverables related to Process Validation Compliance.

Support the review/approval of validation protocols and final reports (Cleaning, Engineering, Development and PPQ Reports).

Provides direct coaching, training, and mentoring to Validation Manager(s) / direct reports. Develops and supports a high

performing team environment that partners with key stakeholders and operates with strong process knowledge and risk-based

decision making to ensure success of the project.


Key Requirements:

• Minimum of Bachelor's degree in Science/Engineering or a related field.

• Minimum of 7 years of experience or combination thereof in a biopharmaceutical environment and in-depth knowledge of the biologic product license application process, and the associated regulatory requirements is mandatory.

• Working knowledge of Production shop floor systems and processes. In-depth knowledge of the principle discipline – validation and biopharmaceutical industry compliance and data integrity assurance (i.e cGxPs, 21 CFR Part 11 & EU Annex 11, current industry standards and practices, and process/environmental engineering).

• Working knowledge and hands-on experience with production processing including automation, scientific writing, effective oral and written communication skills, innovative thinking, and strong compliance mindset. Familiarity with strategic planning, balanced judgement, and risk analysis.

• Strong presentation, communication, and organizational skills.

• Good understanding of current and evolving regulatory requirements (FDA/EU/ICH/ISO).

• Strong communication, interpersonal skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi. Good interpersonal and influencing skills are important for a candidate's success in this role.

• Conflict resolution and problem solving.

• Ability to effectively represent the organization on matters pertaining to policies, plans, and objectives.

• Look internally and externally for best practices and challenge the status quo.

• Ability to be candid and direct, be comfortable with ambiguity and complexity.