Senior Process Engineer

Job Description Summary

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.

Job Description

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 Bachelor's 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 1,800 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 Canada’s 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 :

$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.