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Validation Engineer III
2 months ago
Immediate need for a talented Validation Engineer III (Engineering) . This is a 12+months contract opportunity with long-term potential and is located in Toronto, ON(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-39375
Pay Range: $55 - $59/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- 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 and Technology Experience:
- Key Skills: Cleaning Validation, CQV(commissioning, qualification validation), regulatory requirements (FDA/EU/ICH/ISO).
- 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 Client.
- 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.
Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
