Job Description

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.

Job Summary

To provide process engineering support to Manufacturing and Packaging Departments by managing manufacturing and packaging projects, including the introduction of new manufacturing and packaging technology.


To carry out the activities related to CPL's Validation Program ensuring that these activities meet current GMP/cGMP requirements as well as by ensuring that they allow for the optimization of processes, systems and equipment through effective execution of equipment qualifications and process validations.

JOB RESPONSIBILITIES:

Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by CPL; reports any injury or illness immediately and notifies CPL of any hazards, unsafe acts or conditions in the workplace. Prepare and execute protocols/documents for cleaning, process and packaging validation and generate Validation Summary Reports in accordance to GMP and CPL's Validation Master Plan. Good understanding of project management including identification, justification, risk assessment, ROI, cost management, time management, scope management and resource management. Design conceptual layout of plant & production automation projects & manage the project from conception to implementation. Prepare User Requirement Specifications (URSs) for new equipment and participate in FAT (Factory Acceptance Testing) and installation processes. Develop project cost estimates & project timelines. Participate in the development of capital budgets. Generation and execution of equipment and system's qualification (Installation and Operation Qualification). Generate 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. Provide engineering support and lead troubleshooting efforts on the production floor. Lead production equipment projects including project analysis, planning, design, sourcing, ordering & implementation. Participate in customer related problem solving, process optimization, equipment selection and customer audits and visits. Manage, document and execute line trial activities. Initiate equipment-related change controls. Include "safe design" concepts in automated and process systems. Design lean process concepts such as continuous quick change, clean in place and tool-less changeover. Assist in the development of routings

REQUIRED QUALIFICATIONS:

Education:

Bachelor's degree in engineering and P. Eng designation or working towards P. Eng.

Experience:

Experience (3+ years) related pharmaceutical experience

Knowledge, Skills, Abilities:

Good understanding of CPL's capabilities and processes, including equipment, facility and building qualification and validation. Capable of writing qualification/validation documentation with minimal supervision. Ability to execute projects medium-size projects with minimal supervision. Interact and correspond with CPL customers, vendors and contractors with minimal supervision/guidance. Problem Solving-Higher number of technical decisions within normally established guidelines with minimal supervision from Management. Provides direction on activities on the production floor (lean training, process validation training of operators, batch record training, equipment training) 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 including project identification, justification, risk assessment, ROI, cost management, time management, scope management and resource management. Demonstrated leadership capabilities/competencies: Provide guidance on the work of Level I engineers + Initiate to identify projects
+ Issues on the floor
+ Bringing projects forward

PHYSICAL DEMANDS/WORKING CONDITIONS:

Office environment and support in production area.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us.


We thank all applicants for their expression of interest; however, only those selected for an interview will be contacted. No phone calls or agencies please.