Job description
We are seeking an experienced Senior Validation Engineer to support a large-scale pharmaceutical manufacturing expansion project focused on sterile manufacturing operations. This role will play a critical part in validation, environmental monitoring, sterility assurance, and quality oversight activities associated with a new aseptic filling facility and supporting infrastructure.
The successful candidate will provide technical leadership for environmental monitoring validation, isolator qualification, aseptic process simulation studies, and equipment qualification while ensuring compliance with current GMP regulations and industry best practices.
Location
Toronto, ON, Canada (Hybrid)
Key Responsibilities
Environmental Monitoring & Isolator Validation
- Lead the development, execution, and reporting of Environmental Monitoring (EM) validation programs for sterile manufacturing facilities.
- Serve as Subject Matter Expert (SME) for isolator qualification activities, including FAT, SAT, IQ, OQ, and PQ.
- Design and execute validation strategies covering:
- Viable and non-viable particle monitoring
- Pressure differential qualification
- Airflow visualization studies
- Smoke studies
- Cleanroom qualification
- Develop and validate EM sampling plans, alert limits, action limits, and trend analysis programs.
- Collaborate with Engineering, Manufacturing, and Microbiology teams to integrate validation activities into facility start-up and commissioning schedules.
Aseptic Process Simulation Studies (APSS)
- Lead the design, execution, and reporting of Media Fill studies to support sterility assurance programs.
- Develop APSS protocols, acceptance criteria, and sampling strategies aligned with regulatory expectations.
- Coordinate APSS campaigns with Manufacturing and Microbiology teams.
- Monitor process parameters, environmental monitoring data, and microbiological results during studies.
- Analyze outcomes, identify trends, and recommend corrective or preventive actions when required.
- Maintain APSS lifecycle documentation, periodic requalification plans, and continued process verification activities.
Equipment Qualification & Validation Support
- Support qualification activities for filling equipment, isolators, RABS, utilities, and other process equipment.
- Review and approve validation deliverables including:
- User Requirement Specifications (URS)
- Risk assessments
- Validation plans
- Qualification protocols and reports
- SOPs
- Executed data packages
- Support process validation activities and equipment registration activities.
- Review and assess deviations, change controls, investigations, and CAPAs associated with validation programs.
Quality & Compliance Oversight
- Provide quality oversight for sterility assurance, utilities validation, and computerized systems validation activities.
- Participate in project teams and provide guidance on GMP compliance and validation requirements.
- Maintain awareness of evolving regulatory expectations and industry best practices.
- Identify opportunities for continuous improvement through quality metrics and trend analysis.
- Deliver training and coaching related to validation procedures and compliance requirements.
- Ensure all activities comply with applicable GMP, safety, and quality standards.
Required Qualifications
- Bachelor's degree in Science, Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline.
- 7–10 years of experience within GMP-regulated pharmaceutical environments.
- Strong experience in sterile manufacturing and aseptic processing environments.
- Hands-on experience with isolator qualification and validation.
- Proven experience in environmental monitoring validation and cleanroom qualification.
- Demonstrated experience designing and executing Aseptic Process Simulation Studies (Media Fills).
- Experience qualifying filling equipment, isolators, RABS, utilities, and related process equipment.
- Strong knowledge of:
- EU GMP Annex 1 (2022 revision)
- USP <1116>
- USP <71>
- FDA Aseptic Processing Guidance
- Health Canada GMP requirements
- Excellent technical writing and documentation review skills.
- Strong problem-solving, risk assessment, and cross-functional collaboration abilities.
- Ability to manage multiple validation activities simultaneously in a fast-paced project environment.
Expected Compensation Range:
70K-120K The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.
Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.
Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.
Statement Regarding Job Vacancy:
This position is an existing vacancy/Job creation, created to support ongoing project needs.
Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.
Why choose us
- An international community bringing together more than 110 different nationalities
- An environment where trust is central: 70% of our leaders started their careers at the entry level
- A strong training system with our internal Academy and more than 250 modules available
- A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!