Process Engineering lll

at  Contract Pharmaceuticals

WHO WE ARE:

At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.
For more than 30 years CPL has partnered with the world’s leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.
We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee’s assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

QUALIFICATIONS:

• Minimum 7 years relevant pharmaceutical experience in similar roles, with focus on production floor support, technology transfer and Continuous Improvement initiatives.
• Bachelor’s Degree in an Engineering discipline
• Professional Engineer (P.Eng) designation preferred
• Good understanding of relevant unit operations in the pharmaceutical industry, their capabilities and associated processes. High preference for liquid and semi-solid dose operations.
• Good understanding of automated / integrated production equipment and computerized systems.
• Understanding of qualification and validation of equipment, facility and processes. Capable of writing qualification documentation with minimal supervision.
• Ability to execute medium- to large-scale projects with minimal supervision.
• Experience managing customers, vendors and contractors with minimal supervision/guidance.
• High problem-solving capabilities, ability to address arising issues and make technical decisions within normally established guidelines with minimal supervision from management.
• Good understanding of application of codes and regulations governing the implementation of process and equipment under OBC, OHSA, Fire Code and MOE.
• Good understanding of project management principles including project identification, justification, risk assessment, ROI, cost management, time management, scope management and resource management.
• Good verbal and written English communication skills.
• Demonstrated leadership capabilities/competencies, ability to manage teams and reach goals without formal reporting relationships.

• Actively supports the day-to-day operations of the Manufacturing, Packaging and Maintenance departments. Provides senior technical expertise and guidance in resolving issues and champions sustainable improvement opportunities.
• Manages assigned critical capital projects, supports new product launches and is the voice of the Engineering department in all internal and external forums.
• Prepares and executes qualification documents in accordance to GMP and CPL’s Validation Master Plan.
• Develops and actively leads strategic Engineering projects using sound project management principles, including identification, justification, risk assessment, ROI, cost management, time management, scope management and resource management.
• Prepares User Requirement Specifications (URS) for new equipment and participates in FAT (Factory Acceptance Testing) and installation processes.
• Participates in the development of capital budgets, OPEX initiatives and prioritization of Continuous Improvement projects.
• Generates manufacturing and packaging instructions for new/existing products and/or processes by adapting customer processes to CPL’s equipment and operational requirements through data obtained during line and process test runs. Uses gained knowledge to assist in the development and optimization of routings.
• Provides senior engineering support and leads troubleshooting efforts on the production floor with the help of the Maintenance department.
• Participates in customer process optimization and investigations, equipment selection and customer audits/visits.
• Supports operation of Global Track & Trace functions at CPL from customer onboarding through to management of line-level systems / equipment.
• Manages, documents and executes line trial activities.
• Other duties as assigned.
• Provide technical guidance to Level I and Level II engineers.