The PositionThe Process Engineer position will support the site to onboard new API manufacturing programs. In addition, the role is expected to be a key technical resource supporting new chemical API process implementation.
RelationshipsReports to Associate Director, Operations
Essential Functions- Independently lead or support assigned engineering projects from concept design through start-up
- Responsible for providing input on varying sizes of capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning/qualification and turn-over
- Provide manufacturing and research groups technical support as needed to assist with the day-to-day manufacturing and development activities including, but not limited to new molecule introduction activities (transfer and scale-up), operation and equipment optimization, equipment and process trouble-shooting and continuous improvement goals
- Support EHS activities including chemical and hazardous assessments including participation in PHAs and PSSRs
- Work with internal and external resources to develop and review engineering documentation, technical standards, SOPs, protocols, risk assessments and reports
- Develop, evaluate and implement cost effective engineering solutions for equipment, facility and utility systems
- Support process and automation system designs
- Promote a culture of safe and compliant design and operation
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned
Physical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.
Qualifications- Bachelor's degree in an Engineering or Chemistry field of study from an accredited university required
- Minimum of eight (8) years of relevant work experience to include engineering processes & design and operations support required, preferably in a pharmaceutical manufacturing environment
- Knowledge and experience with two (2) or more of the following required: process utility systems including water, solvent, waste, inert gas, glycol, syltherm and compressed air systems
- Knowledge of process and equipment design and installation required
- Strong understanding of engineering guidelines to include one or more of the following required: CFR, GEP, ASME BPE, ASTM E2500 and ISPE guidelines
- Direct experience and ability to start-up and trouble-shoot equipment required
- Possess excellent writing and communication skills and a demonstrated ability to work independently and with cross-functional teams required
- Ability to lead projects that include managing external vendors with development, design and testing activities is required
- Ability to provide technical leadership on multiple projects operating in parallel required
- Strong understanding of Good Manufacturing Practices (GMPs) a plus
- Experience working with capital engineering projects is preferred
- A working knowledge with pharmaceutical manufacturing process operations is preferred
- Knowledge and experience with the execution of commissioning and validation activities including FAT, SAT, TOP and IQ/OQ/PQ a plus
