Manager Engineering

Applied Pharmaceutical Innovation (API) brings lifesaving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven compassionate and laser focused on making a dramatic positive impact with everything we undertake.

When you join API you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries increasing the amount of commercial research and development in the country and supporting Alberta as a key pillar in Canadas life sciences sector.

You will be part of one of APIs most important projects the Canadian Critical Drug Initiative (CCDI). The CCDI is a project led by API in partnership with the University of Alberta. It aims to establish an integrated research commercialization and manufacturing cluster in the Edmonton Metropolitan Region.

One aspect of the project involves upgrading the Biotechnology Business Development Centre (BBDC) in the Edmonton Research Park. The upgrade will include GMPcertified manufacturing suites for APImanufacturing chemicalphysical testing and Health Canadaapproved warehousing capacity.

The second part of the project is the Critical Medicines Production Centre (CMPC) which will be a new 83000 squarefoot manufacturing facility located on a 7acre plot of land in the center of the Edmonton Research Park. This facility is set to be Canadas largest and best equipped of its kind. The CMPCs focus will be on producing smallmolecule product solutions conducting sterile aseptic fill and finishing traditional and biologic to meet drug shortages needs.

** Please note this position requires fulltime onsite presence.

Key Responsibilities include but are not limited to:

Qualification Activities:

• Compile and review URS documentation for new equipment include but not limited to Formulation reactors/Vessels Autoclaves sterile filling lines Packaging lines automated inspection machines water purification HVAC chemicalanalytical Equipment Microequipment (Isolator Incubator).
• Collaborate with Manufacturing equipment vendors review and approve technical drawings give scientific and engineering input for new Equipment
• Compile GMP FMEA based riskassessment for new equipment and processes
• Support in CleanRoom and Room design
• Creating material process and personnel flows
• Review FAT and SAT protocols
• Perform FAT and SAT with suppliers. Write and review FAT and SAT reports
• Prepare with Suppliers IQ OQProtocols
• Perform with Suppliers and equipment owners IQ/OQ on site write and review IQ/OQreports
• Perform PQ tests together with Equipment owners
• Qualification of Clean rooms
• Review and Requalification of equipment and ensure with equipment owners maintenance and calibration activities
• Perform CSV (computer system validation) activities URS IQ/OQ for equipment and new IT systems including hardware

Engineering operations:

• Review and Requalification of equipment
• Ensure with equipment owners maintenance and calibration activities
• Overseeing implementation of new processes and procedures together with new materials e.g. primary and secondary packaging
• Investigate and troubleshoot any problems that arise with processes procedures and operations including documentation according deviation processes
• Compile Change requests and perform risk analysis.

Project leading activities:

• Identify important Stakeholders and build up project teams
• Proactively manage the delivery of GMP infrastructure projects on time and within scope and budget to ensure project objectives are met.
• Collaborate with project managers CM consultants from design engineering & construction teams to integrate all activities into cohesive scope.
• Manage contracts of consultants and vendors in GMP infrastructure projects including but not limited to: design engineering construction pharmaceutical manufacturing equipment vendors and other consultants as required.
• Manage executive stakeholder relationships and expectations through strategic proactive and professional communication including but not limited to: API senior leadership; API board of directors; municipal provincial and federal government bodies; project partners
• Ensure business decisions are made by the most accountable person in consultation with appropriate representation from all impacted functional areas.
• Consistently identify track and manage risks assumptions issues and decisions with the project team.
• Develop response plans as needed to address identified risks.
• Assign ownership of issue resolution and problemsolving holding responsible parties accountable as needed
• Provide a collaborative environment for resolving issues effectively escalate issues only when necessary.

Education

• A Bachelors or Masters degree in an engineeringrelated science discipline preferably with experience in the pharmaceutical industry.

Experience:

• Proven work experience in process and/or mechanical and/or validation engineering
• Excellent technical skills
• Knowledge of process related standards
• Familiarity with health and safety regulations
• 3 years of experience with process mechanical design and/or manufacturing engineering experience preferably in the pharmaceutical
• Management in Departmental Expenses and Capital Expenditure (CAPEX)
• Prepared User Requirement Specifications (URS) and related documentation for process equipment and utilities
• Familiarity with Data Management Integrity and Records
• Extensive knowledge and applied experience in project management principles and the Project Management Body of Knowledge (PMBOK).
• Demonstrated ability to organize and manage full range of project work from small details to the big picture with competing priorities.
• Demonstrated leadership team building and relationship management.
• Able to complete supplier reviews/audits/evaluations Factory Acceptance Testing (FAT) inside and outside of Canada
• Experience working in a sterile manufacturing environment preferred.
• Current Professional Engineer (PE) license preferred.
• Experience over a wide range of pharmaceutical equipment operations and validation preferred.
• Experience in validating pharmaceutical air systems and Building Management Systems (BMS) preferred.
• Experience with GAMP 5 practices (Good Automated Manufacturing Practices V) preferred.
• Proficient with computeraided engineering (CAE) and computeraided manufacturing (CAM) preferred.

Personal Competencies:

• Exceptional communication and interpersonal skills with the ability to interact with stakeholders at all levels.
• Strong leadership and team management skills with the ability to motivate and guide teams toward project success.
• Excellent organizational planning and prioritization skills
• Analytical problemsolving and clear communication skills
• Relationship building influencing advocating and negotiating capabilities.
• Comfort with ambiguity and cultural differences.
• Excellent written communication and interpersonal skills
• Exceptional attention to detail
• Effective in a fastpaced startup environment
• Proactive analytical resultsoriented and creative
• Fosters transparent honest and positive team environment.
• Resultsdriven and processoriented

Working Conditions:

• Required travel between Edmonton API sites
• Required to travel to several worldwide locations of vendors/suppliers especially USA and Europe.
• This position requires you to be on site.
• Office and laboratory settings.
• Possible exposure to chemicals machinery or equipment.

Additional Required Documents to Support Application

• Applications submitted without a resume & cover letter will not be reviewed.

Perks and Benefits at API

Comprehensive Health Coverage: At API we prioritize the wellbeing of our employees. We offer a comprehensive health coverage plan. Our premiums are 100 covered ensuring that you and your dependents receive the necessary healthcare support.

Payment in Lieu of Pension: API provides an additional 15 of your annual base salary as an alternative to traditional pension benefits.

Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities including training programs workshops conferences and certifications. We encourage employees to enhance their skills broaden their knowledge and stay updated with the latest advancements in the life sciences industry.

Collaborative and Inclusive Environment: At API we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork open communication and a supportive atmosphere where everyones contributions are valued.

Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy worklife balance. API offers a generous paid time off (PTO) policy that includes vacation days medical/personal days and holidays. We encourage our employees to prioritize their wellbeing and enjoy quality time away from work.

Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program which promotes the use of environmentally friendly modes of transportation. By participating in the program you commit to making green transit your primary mode of transportation for at least 75 of your commute to and from work. Green transit includes walking biking carpooling and public transportation.

How to Apply

Interested applicants must submit a resume and cover letter expressing their interest in the position and why they believe they are a strong candidate.

We appreciate all applicants interest and will only contact those selected for interviews.

If you have any questions about the application process or require accommodations during the hiring process please contact .

Our team clients and stakeholders come from a variety of backgrounds. In recruiting for our team we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences education culture gender race sexual orientation religious or ethnic background neurodiversity and cognitive and physical ability.

Before employment successful candidates will be required to meet the requirements of a preemployment screening which includes background reference checks educational credential verification and criminal reference checks.

Application Deadline: April 9 2025