Manufacturing Process Engineer

Job Title: Manufacturing Process Engineer

Job Description

The Manufacturing Process Engineer supports the design, modification, qualification, and optimization of pharmaceutical manufacturing processes and facilities in a GMP-regulated environment. This role focuses on facility upgrades, process implementation, equipment integration, and validation activities that enable both new and existing manufacturing operations. The engineer collaborates closely with Manufacturing, Quality, Validation, Regulatory, and Project teams to develop robust technical solutions, manage process changes, and ensure full compliance with regulatory and contamination control requirements while contributing to innovative medical and nuclear medicine solutions.

Responsibilities

• Support facility and process redesign projects, including the implementation of new manufacturing systems and equipment in GMP-regulated pharmaceutical and medical manufacturing environments.
• Review existing process, equipment, and facility documentation to inform engineering decisions and support effective project execution.
• Develop technical solutions that enable multiple manufacturing processes to operate within shared GMP facilities while minimizing contamination and cross-contamination risks.
• Support equipment installation, commissioning, qualification, and validation activities to ensure reliable and compliant operation.
• Lead or contribute to process scale-up, technology transfer, and continuous improvement initiatives that enhance manufacturing efficiency and product quality.
• Execute qualification and validation activities, including the development and completion of IQ/OQ/PQ protocols, test plans, and validation reports.
• Perform risk assessments to identify, evaluate, and mitigate manufacturing and process risks throughout the product and process lifecycle.
• Apply design control and change control principles within highly regulated manufacturing environments to maintain compliance and traceability.
• Collaborate with Manufacturing, Quality, Validation, Regulatory, and Project teams to ensure compliant, effective, and timely process implementation.
• Generate, review, and maintain technical documentation, specifications, validation records, and engineering reports to support audits and regulatory submissions.
• Contribute to research and development activities related to medical manufacturing solutions, facilities design, and process development.
• Participate in or support automation and lean six sigma initiatives aimed at improving manufacturing processes, throughput, and reliability.
• Demonstrate the ability to lead project tasks, coordinate cross-functional activities, and implement practical technical solutions within project timelines.
• Apply Good Manufacturing Practices (GMP) and Good Design Practices to all aspects of process and facility design, validation, and operation.
• Support regulatory compliance efforts by ensuring that processes, documentation, and validation activities meet applicable pharmaceutical and medical regulatory requirements.

Essential Skills

• 5+ years of manufacturing process design experience in the pharmaceutical or medical development industry.
• Direct experience with medical manufacturing process design and technical engineering design for medical products or solutions.
• Demonstrated experience and understanding of pharmaceutical development processes and regulatory requirements.
• Solid technical knowledge within process or manufacturing engineering, with a broad understanding of other engineering disciplines.
• Direct experience with regulatory and pharmaceutical projects, including application of Good Manufacturing Practices (GMP) and Good Design Practices.
• Experience with clean room design and operation, including contamination control strategies and environmental monitoring considerations.
• Experience with aseptic processing and terminal sterilization methods in regulated manufacturing environments.
• Hands-on experience with validation protocols and the full qualification and validation lifecycle, including IQ/OQ/PQ activities.
• Experience with technology transfer and process scale-up from development to commercial manufacturing.
• Proven ability to lead project tasks and implement technical solutions within a structured project management framework.
• Experience applying design control and change control in highly regulated manufacturing environments.
• Strong understanding of regulatory compliance requirements in pharmaceutical and medical manufacturing.
• Proficiency in generating and maintaining detailed technical documentation, specifications, and validation records.

Additional Skills & Qualifications

• Experience with process engineering and manufacturing engineering in pharmaceutical or medical manufacturing settings.
• Experience in process improvement and process development, including continuous improvement methodologies.
• Exposure to research related to medical solutions for facilities design and development.
• Experience with automation in manufacturing environments to enhance efficiency and reliability.
• Familiarity with lean six sigma principles and tools for process optimization.
• Experience with equipment validation and qualification in GMP-regulated facilities.
• Knowledge of quality engineering practices and their application to manufacturing processes.
• Strong documentation skills and attention to detail in preparing engineering reports and validation records.
• Ability to collaborate effectively with cross-functional teams including Manufacturing, Quality, Validation, Regulatory, and Project Management.
• Broad understanding of project management frameworks and the ability to work within structured project plans.

This is a Contract position based out of Ottawa, ON.

The pay range for this position is $50.00 - $65.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

This is a Contract position based out of Ottawa, ON.

This is a fully onsite position in Ottawa,ON.

À propos d'Actalent

Actalent est un leader mondial dans les services dingénierie et de sciences ainsi que dans les solutions de talents. Nous aidons des entreprises visionnaires à faire progresser leurs initiatives dingénierie et de science grâce à laccès à des experts spécialisés qui favorisent léchelle, linnovation et la rapidité de mise sur le marché. Avec un réseau de près de 20 000 consultants et 5 000 clients à travers les États-Unis, le Canada, lAsie et lEurope, Actalent dessert de nombreuses entreprises du Fortune 500. Nous sommes fiers dêtre lune des 500 meilleures firmes de conception de lEngineering News-Record (ENR) pour nos services de conception en ingénierie et un lauréat du prix ClearlyRated Best of Staffing® tant pour le service client que pour les talents.

Actalent est un employeur souscrivant au principe de légalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de lâge, de la couleur, de la religion, des origines nationales, du statut dancien combattant, dun handicap, de lorientation sexuelle, de lidentité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi.

Si vous souhaitez faire une demande daccommodement raisonnable, tel que la modification ou lajustement du processus de demande demploi ou dentrevue à cause dun handicap, veuillez envoyer un courriel à [email protected] pour connaître dautres options daccommodement.

Ordonnance sur légalité des chances de San Francisco: Conformément à lOrdonnance sur légalité des chances de San Francisco, pour tous les postes situés dans la ville et le comté de San Francisco, nous examinerons les candidatures des personnes qualifiées ayant un casier judiciaire ou des antécédents criminels.

Utilisation de lintelligence artificielle (IA): Nous pouvons utiliser lintelligence artificielle (IA) pour soutenir certaines étapes de notre processus dembauche, notamment la recherche, la présélection et lévaluation des candidatures. LIA aide à analyser les candidatures et les qualifications, mais les décisions finales sont prises par notre équipe de recrutement. En soumettant votre candidature, vous reconnaissez et acceptez que celle-ci puisse être examinée à laide doutils dIA.

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 20,000 consultants and 5,000 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 [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.