CQV Engineer

PharmEng Nordic ApS; Toronto; Vor Ort; CAD 85.000 - 125.000; Vollzeit

Benefits dieser Stelle

Competitive wages

Comprehensive benefits package

Paid holidays

Travel opportunities

Zusammenfassung

PharmEng Technology in Toronto seeks an experienced CQV Engineer to support commissioning, qualification, and validation activities across site and projects.

The ideal candidate will have 2–5 years CQV experience in pharma/biotech, a technical bachelor's degree, and strong knowledge of cGMP and regulatory requirements. Travel opportunities may be required.

Qualifikationen

• 2–5 years of applied technical CQV experience in pharma/biotech
• Hands-on commissioning, qualification and validation across disciplines like facilities/utilities/equipment
• Strong understanding of cGMP and regulatory requirements

Aufgaben

• Provide direct CQV services to site Technical Services management to increase throughput of commissioning/qualification activities
• Perform activities related to validation independently and across the site as directed
• Review commissioning/qualification documentation for accuracy and regulatory compliance
• Support development of user requirements and functional specifications for CQV projects
• Generate and execute commissioning/qualification documentation for demonstration batches, validation studies and final reports

Kenntnisse

CQV experience

Engineering background

Validation

Ausbildung

Bachelor's degree in engineering/technical field

Jobbeschreibung

PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.

At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.

We are seeking an experienced CQV Engineerbased inToronto, Ontario, to help drive our solution-based business model and take our designs to the next level. Our Consultants have the chance to work hands-on with several business divisions to design, develop, and test industry-leading solutions for our clients—both nationally and internationally. Our ideal candidate is a creative thinker who shares our passion for making people’s lives easier.

Job Description:

• Responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
• Will work with Technical Services management but be expected to perform required activities related to validation independently.
• This position will support C&Q activities across the site as directed by site Technical Services management.
• Review site commissioning and qualification documentation for accuracy, technical soundness and compliance to both site and regulatory guidelines.
• Projects may include new facilities/equipment startup, commissioning, FAT, manufacturing equipment qualification, laboratory equipment qualification and computerized and automation systems including FMS and BMS systems.
• Provide support for the development of user requirements and functional specifications.
• Support the generation and execution of all commissioning and qualification documentation related to demonstration batches, thermal studies, validation studies for equipment, facilities, utilities, engineering test runs, development studies, software validation and final reports.
• Recommendations to management as to the acceptance and release of qualified systems.
• Actively participates during all phases of validation projects. Evaluates projects, provides technical information to others.
• Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues.
• Review various documentation and drawings to ensure any document changes, meet quality and validation requirements and are in full compliance with regulations and standards.
• Provide technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformances.
• Support, investigate and troubleshoot problems and determine possible solutions.
• Provide effective solutions for the management of system deviations and non-conformances.

Job Requirements:

• Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy)
• Two (2) to five (5) years of applied technical experience within the CQV space of the pharmaceutical, health sciences, or biotech industries.
• Hands on commissioning, qualification and validation experience in at least two (2) of the following disciplines is preferred: Facilities (including design, flow analysis, HVAC), Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems), major equipment, process / cleaning and equipment validation / qualification or computer software validation.
• Firm understanding of cGMP validation requirements / guidelines and current industry practice.

Why PharmEng Technology?

Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone’s unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.

What We Offer:

• Comprehensive benefits package & competitive wages.
• A supportive environment where employee growth is promoted.
• Paid holidays.
• Other great incentives.

EEOC Statement

At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.

Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.