Senior Process Engineer

STICA STEMCELL Technologies Canada; Burnaby; On-site; CAD 81,000 - 123,000; Full time

Job summary

A biotechnology company in Metro Vancouver is seeking a Senior Process Engineer to lead the design and validation of cGMP processes for nanoparticle products. The ideal candidate will have a relevant engineering degree and extensive experience in process design. Responsibilities include collaborating with cross-functional teams and ensuring compliance with regulations. This role offers a competitive salary starting from $81,700 to $122,500, along with a comprehensive benefits package.

Benefits

Competitive salary

Comprehensive health benefits

Retirement savings plan

Meaningful career development opportunities

Qualifications

• 5-10 years of experience in cGMP process design, development, and implementation.
• Experience in developing protocols for pharmaceutical or biotech equipment.
• Familiarity with aseptic and fill-finish processes.
• Competency in equipment design software.

Responsibilities

• Collaborate with teams to develop scalable, validatable manufacturing processes.
• Oversee equipment design, documentation, and compliance with GMP regulations.
• Draft and review technical documentation with cross-functional teams.
• Ensure timely delivery of project deliverables.

Skills

Problem-solving

Networking

Communication

Attention to detail

Education

Bachelor's degree in relevant engineering discipline

Tools

AutoCAD

SolidWorks

Job description

Overview

The Process and Analytical Development team is looking for a highly motivated Senior Process Engineer to join our New Product Introduction & Scale-up Team. As a Senior Process Engineer you will be joining a highly experienced and collaborative Process Development team focused on delivering robust cost efficient and competitive products and manufacturing processes. You will be responsible for leading the design qualification and process validation effort to develop and commercialize a fully compliant cGMP nanoparticle product. This is a fantastic opportunity to apply your critical thinking skills and contribute to STEMCELL's goal of supporting cutting edge research in the life sciences field. Successful candidates should have strong problem solving and networking skills and be able to work effectively in a dynamic and cross functional team.

Duties and Responsibilities

• Collaborate with process development and R&D scientists and engineers to develop and implement scalable validatable robust and reliable manufacturing fill-finish & terminal sterilization processes
• Facilitate the seamless transition of initial designs to scale-up and technology transfer ensuring safety consistency and quality throughout the product development lifecycle
• Oversee and support process equipment design and documentation evaluation selection and approval of third-party equipment as required by applicable GMP manufacturing regulations
• Draft and review technical documentation including engineering reports risk assessments and standard operating procedures in collaboration with Manufacturing and Quality teams
• Work collaboratively with quality regulatory analytical manufacturing procurement and project management teams and stakeholders to ensure on budget and timely delivery of project deliverables

Knowledge and Qualifications

• A minimum of a Bachelors degree in a relevant engineering discipline with a combination of 5-10 years of additional educational and / or professional experience.
• Broad knowledge of cGMP process design development and implementation in a regulated industry (e.g. pharmaceuticals biotechnology medical devices).
• Experience developing and executing commissioning qualification and validation protocols for pharmaceutical or biotech equipment and processes.
• Experience with the practical design and operation of aseptic processes and fill-finish processes; experience in the design and validation of terminal sterilization processes of liquid products (e-beam gamma x-ray) would be an asset.
• Competency in commonly used equipment design software (e.g. AutoCAD SolidWorks) is an asset
• Strong verbal and written communication skills with excellent organizational skills and attention to detail.
• STEMCELL Technologies is a privately owned Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality we are a company of Scientists Helping Scientists standing by our customers to provide the outstanding products technical support and training they need to advance their research. Scientists performing stem cell immunology cancer regenerative medicine and cellular therapy research are among those who rely on our cell culture media cell separation products instruments accessory products and services. Through our many regional offices as well as our distribution centers in Vancouver Seattle Grenoble and Singapore we deliver our innovative specialized products to more than 100 countries. With over 1800 employees globally most with scientific or engineering degrees STEMCELL is proud to be the largest biotechnology employer in Canada.
• This is an opportunity to work with highly motivated colleagues in a science-oriented creative and dynamic environment. We offer a competitive salary excellent benefits and meaningful career development opportunities.
• STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canadas Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
• As an equal opportunity employer STEMCELL is dedicated to ensuring that every employee feels safe valued and respected for who they are. We know that scientific progress and innovation occur when diverse creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
• The annual base salary for this job ranges from :

Salary: $81,700.00 - $122,500.00

STEMCELL determines an individual's pay within the range based on multiple factors including experience education job-related skills and equity within the team or organization. For jobs that are eligible for sales incentives the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary STEMCELL offers a comprehensive total rewards package including health benefits retirement savings and more.

How to Apply

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Requirements

• Required Experience: Senior IC
• Employment Type: Full-Time
• Experience: years
• Vacancy: 1