Manufacturing/Process Engineer

Job Title: Manufacturing Engineer
Job Description

Join a dynamic team to assist with upscaling efforts as we approach end-of-year deadlines for an exciting product launch. You will execute the transfer of manufacturing processes and technologies from Research and Process Development groups into a cGMP environment. Design appropriate manufacturing processes, conduct process development activities, and provide necessary design transfer inputs as part of Tech Transfer.

Responsibilities

• Identify potential risks, evaluate impacts of manufacturing process steps and raw materials on product performance, and develop risk mitigations as part of the tech transfer and scale-up.
• Interface with Engineering teams to define and establish manufacturing and inventory control processes for reagents, consumables, and instruments.
• Support Assay Development and Engineering teams to ensure the manufacture and supply of prototype consumable assemblies needed for assay design verification and clinical validation activities.
• Establish appropriate manufacturing processes and controls to maintain consistency and quality from prototype through production scale-up.
• Utilize knowledge and experience to develop, assess, implement, and enhance cGMP manufacturing processes and operations continually.
• Lead comprehensive validation activities, including planning and execution of validation protocols for equipment, facilities, and processes.
• Identify, procure, install, qualify (IQ, OQ, PQ), and maintain critical manufacturing equipment.
• Create and maintain cGMP manufacturing documentation, such as Work Instructions and acceptance plans and records.
• Support the creation and maintenance of Standard Operating Procedures (SOPs) for ISO13485 and cGMP processes.
• Perform Root Cause Analysis of manufacturing failures with cross-functional team members to determine failure causes and implement improvements.
• Drive Continuous Improvement in manufacturing by identifying improvement opportunities and developing and implementing process improvements.

Essential Skills

• Process engineering
• Manufacturing engineering
• Lean manufacturing
• Six Sigma
• Troubleshooting
• Biochemistry
• Medical device
• Process Validation experience
• Root Cause Analysis

Additional Skills & Qualifications

• Degree in mechanical engineering, mechatronics, or biochemistry
• Experience in process engineering for medical devices or biochemistry
• Experience with diagnostics, reagents, biologicals
• Experience in high-volume automated assembly processes
• Knowledge of Automation, Molded Plastics, Food and Beverage, ISO13485

Work Environment

Enjoy working in a clean, well-lit environment where teamwork and family values are prioritized. This is a smaller startup that is rapidly growing, offering a great opportunity to learn and potentially transition to full-time employment. Full benefits are available upon full-time employment, including a $150/month health and wellness spending allowance and stock options. Work hours are 8 am to 5 pm, Monday through Friday, with occasional overtime.

Pay and Benefits

The pay range for this position is $40.00 - $52.00/hr.

Workplace Type

This is a fully onsite position in Oakville,ON.

À propos d'Actalent:

Actalent est un chef de file mondial des services d’ingénierie et de sciences et des solutions de talents. Nous aidons les entreprises visionnaires à faire progresser leurs initiatives en matière d’ingénierie et de science en leur donnant accès à des experts spécialisés qui favorisent la mise à l’échelle, l’innovation et la mise en marché rapide. Avec un réseau de près de 30 000 consultants et plus de 4 500 clients aux États-Unis, au Canada, en Asie et en Europe, Actalent est au service d’un grand nombre d’entreprises du classement Fortune 500.

Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.

Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à actalentaccommodation@actalentservices.com pour connaître d’autres options d’accommodement.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.