Engineer Process Development Jobs in Richmond, British Columbia

Participate in risk management activities related with new or modified products or processes following ISO 14971

Knowledge of or experience with ISO 13485, ISO 9001

Use Six Sigma methodology to analyse data to determine process performance and monitoring requirements

Minimum 4 years’ industry experience and a track record of working in a GLP, GMP, and/or similarly regulated work environment

Must have process validation experience using industry standard methods for IQ, OQ and PQ

Must have experience with design/tech transfer activities for medical devices, pharma or other highly related manufacturing processes

Experience in technology transfer to manufacturing facilities, including CDMOs

Support the development plans and activities for cGMP antibody production and be accountable for resulting project deliverables

Develop and execute downstream processes and their technology transfer to CDMOs

Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed

Maintain documentation such as work instructions, data recording forms, engineering change management process, etc.

Thorough knowledge of and experience with Microsoft office products, AutoCAD, and SolidWorks

Hold a technical degree or diploma specializing in mechanical, electrical, or chemical engineering or equivalent experience

Knowledge of statistical methods including 6-Sigma techniques

Knowledge of Lean Manufacturing principles

Good communication and interpersonal skills, along with the ability to work well in cross-functional teams

BSc with minimum 3 to 6 years relevant industry experience or MSc with 0 to 4 years of relevant experience

Hands-on experience with mammalian cell culture of adherent and suspension cell lines is essential

Experience with high throughput experimentation and mechanistic modeling, experience with micro, bench, and pilot-scale bioreactors is desirable

Experience in media/feed development and depth filtration is an asset

Good problem solving skills with a systematic analytical approach

Contribute towards development, optimization, and implementation of scalable Upstream protein (e.g. monoclonal antibodies, fusion proteins) production processes to meet project timelines

· Project Management including purchasing, implementation and releasing of new machines.

In addition, the following skills are preferred:

· MS Office skills (advanced user)

· Excellent interpersonal skills, can do attitude and adaptable

· Interest and basic knowledge of aviation industry

· Engine manual research for new products to identify tool and process requirements

Good time management, effectively organizing, prioritizing and meeting deadlines.

Education: Minimum 3rd year of Bachelor’s degree in Chemical/Mechanical Engineering.

Experience: 4-8 months co-op/intern experience in a related industry is preferred

Programming experience (MATLAB, Python) is an asset.

Knowledge of process control and instrumentation.

Strong analytical and problem-solving skills with ability to make sound recommendations.

Collaborate with internal and external resources to develop qualification strategies for incoming primary and pluripotent cells.

Education: Bachelor’s or Master’s degree in life sciences or engineering.

Become process subject matter expert and work with process development and manufacturing teams to ensure technical compliance and adherence

Develop and execute drug substance process optimization and characterization projects to achieve specific project and company milestones

Perform laboratory-based studies to qualify biocompatible materials for incorporation into bioprinted pancreatic tissues

Work with Aspect’s R&D and Engineering teams to generate, optimize, and characterize bioprocessing processes which are suitable for specific tissues/indications

Thorough understanding and hands-on experience of developing downstream processes for use in a cGMP manufacturing environment

Experience in technology transfer to manufacturing facilities, including CDMOs

Experience in leading and managing cross-functional projects is required

Create the development plans for clinical protein production and be accountable for resulting project deliverables

Provide oversight and guidance on downstream processes and their technology transfer to CDMOs

Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed

Prior experience working with Google Suite, Principles of Quality by Design, Product LifeCycle Management (PLM) and SAP interface is highly desired

Prior experience in cell culture and/or cell culture media development is an asset

General knowledge of biological raw materials, ISO 9001, ISO 14001 are desired

Experience in contributing to cross-functional projects is required

Nurture collaborations to deliver non conformance investigation reports on time and ensure all non conformance investigation related activities are documented appropriately

Provide technical support towards Media production services and batch record documentation as required

Experience in technology transfer to manufacturing facilities, including CDMOs

Support the development plans for clinical antibody production and be accountable for resulting project deliverables

Develop and execute upstream antibody production processes and their technology transfer to CDMOs

Author and review process descriptions, technical reports, technology transfer documentation, SOPs, batch records, regulatory filings and other documentation as needed

Participate in improvement initiatives that expand knowledge of process fundamentals necessary to further define and improve performance metrics

A minimum of 4 years of working experience in the mining industry or environment

Strong interpersonal, oral, and written communication skills

Good critical thinking, data analysis and problem-solving skills

Be a courageous safety leader, adhere to and sponsor safety and environmental rules and procedures

Identify process and metallurgical deviations in a timely fashion and maintain appropriate control instructions that promote stable and profitable operation

Provide verbal and written reports to keep management and work teams informed on progress of the assignments

5+ years’ experience in chemical, processing, or metallurgical engineering

Experience with process development and plant evaluations (pilot or full scale) is essential to this role

Experience in implementing new technology is desirable

Advanced analytical, problem solving and decision-making abilities

Excellent interpersonal and communication skills

3-10 years of professional experience with a focus on metallurgical and mineral processing or chemical engineering;

Experience with copper, lead, zinc, moly, and gold metallurgy are considered an asset;

Experience with flotation design is considered an asset;

Experience with comminution design is considered an asset;

Site and project experience is highly desired;

Experience in using METSIM, IDEAS, SysCAD, JKSimMet and other process simulation software is considered an asset;

A working knowledge of the fundamental requirements of process engineering, and the basic requirements of other engineering fields.

Education – Qualifications, Accreditation, Training

Sound technical and practical engineering skills and ability to consistently deliver quality, accurate and timely work to Worley and its customers.

A working knowledge of applicable local and international standards and statutory and regulatory specifications.

Engineering experience in the same or similar industry.

Deliver process engineering services that meet Worley, its customers and applicable statutory and regulatory specifications, on time and within budget.

Knowledge of hygienic standards & requirements

Floating of enquiries, vendor offer review and preparation of TBA and supporting client in finalization of vendors

Experience in carrying out brownfield projects including analyzing bottlenecks, identifying improvement options and aligning with Client

Knowledge of generating Cost estimation.

Evaluation of vendor offers and preparation of Technical Bid Analysis (TBA)

Experience in Project execution including coordination with Site team, vendors and contractors for installation and commissioning

Collaborates with the Risk Management Team in the conduct and documentation of process risk analyses

A great working environment with opportunities to develop your skills and knowledge

Supports production change control activities, including development and maintenance of manufacturing process requirements and control plans

Proven experience with taking the lead with troubleshooting techniques, problem-solving, and root cause analysis

A sound knowledge of statistics, SPC, FMEA, and process capability is strongly desirable

Proven written and verbal communication and technical documentation skills

A competitive base salary reflective of your skills and experience with annual incentive program

A proven aptitude for problem-solving and statistical data analysis with 3+ years of industrial work experience

Collaborative attitude and strong communication skills – ability to communicate complex technical information simply and succinctly

Experience with Lean Six Sigma methodology

Career development & education assistance to further your technical or leadership ambitions

Be part of a group that is safety driven and values inclusion

Supports continuous improvement and change management efforts

Manages assigned budget, schedule, and quality requirements

Typically assists with performance management process, mentoring, recognition, and any corrective actions required

Consistently and independently applies knowledge and complies with Black and Veatch quality program relative to assigned tasks

Intermediate knowledge of engineering design principles and applicable design guides and standards related to assigned engineering discipline

May be responsible for ensuring compliance with Black and Veatch quality program

Solving complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment

Using your experience in scale-up (AKTA Pilot) and/or scale-down processes to aid CMC development work

M.Sc/B.Sc and 2-5 years of relevant work experience in downstream process development within a biotechnology or pharmaceutical organization

Experience with bioanalytical assays associated with purification processes, such as SDS-PAGE, Western blotting, HPLC, etc. is highly desirable

Superb oral and written communication skills, including presentation of complex data

Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional teams

We are looking for an experienced individual to join our Process Group.

- 10 years of experience as a Kraft pulp mill process engineer

- Excellent report writing and presentation skills.

- Excellent Word and Excel skills.

About A.H. Lundberg Systems Ltd:

- Design Process & Instrument Diagrams