21 Oct
|
Amaris Consulting | Part of Mantu
|
Scarborough
21 Oct
Amaris Consulting | Part of Mantu
Scarborough
We are seeking a Validation Engineer HVAC & Equipment to support HVAC and equipment qualification and validation activities within a pharmaceutical manufacturing environment. In this short-term contract, you will contribute to the preparation, execution, and closure of qualification protocols while ensuring all work meets GMP/cGMP requirements and audit-readiness standards. You will work closely with engineering, quality assurance, facilities, and project teams to deliver validation milestones on schedule.
- Location: Scarborough, Ontario
- Work mode: Onsite
- Length of the contract: 3–4-month duration with possible extension after February 2027
Key Responsibilities
- Support HVAC system qualification and validation activities, including air handling units (AHUs), ductwork, filtration systems, pressure cascades, and environmental monitoring.
- Assist in the preparation, execution, and closure of equipment and HVAC qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Prepare and review validation documentation, including qualification protocols, test records, technical reports, and final summary reports, ensuring compliance with GMP/cGMP.
- Review engineering drawings, technical specifications, equipment documentation, and vendor deliverables to verify compliance with project requirements and applicable quality standards.
- Maintain complete, accurate, and traceable qualification and validation records in accordance with Good Documentation Practices (GDP) and audit-readiness requirements.
- Support the development and maintenance of Continuous Validation Plans, ensuring qualification activities and documentation remain current.
- Identify, document, and follow up on deviations, non-conformances, and change controls related to equipment qualification and HVAC systems.
- Collaborate with engineering, quality assurance, facilities,
and project teams to support timely completion of qualification and validation deliverables.
- Assist with the review and organisation of HVAC-related software records and supporting documentation, where applicable.
- Ensure assigned activities are completed according to approved procedures, project timelines, and pharmaceutical quality requirements.
Required Qualifications
- Bachelor's degree or technical diploma in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or a related engineering discipline.
- 1–5 years of experience in qualification, validation, commissioning, or engineering projects within the pharmaceutical or other regulated industries.
- Basic knowledge of HVAC systems, including AHUs, ductwork, filtration systems, pressure cascades, and environmental monitoring.
- Experience supporting equipment qualification activities, including IQ, OQ, and PQ.
- Knowledge of GMP/cGMP and pharmaceutical quality requirements.
- Familiarity with Continuous Validation Plans and the preparation, execution, and maintenance of qualification and validation documentation.
- Ability to review technical drawings, equipment specifications, vendor documentation, and test records.
- Understanding of deviation management, change control processes, and GDP.
- Strong attention to detail and organisational skills, with the ability to maintain accurate, complete, and audit-ready documentation.
- Self-motivated and quick to learn, able to work independently with minimal supervision.
- Fluent in English,
with strong written and verbal communication skills.
- Familiarity with HVAC-related software or tools used in engineering, qualification, or validation activities.
Expected Compensation Range:
65-90K 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 a 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 setting 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.
📌 Validation Engineer (Scarborough)
🏢 Amaris Consulting | Part of Mantu
📍 Scarborough