Process Chemical Engineer (All Levels)
Develops, prepares and tests materials, prototypes and finished products in support of prototype drug product screening, process optimisation and scale-up.
- Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
- Applies technical chemistry knowledge to innovate, design, develop and characterise processes, procedures, tooling and/or automation.
- Conducts wet chemistry techniques towards synthesis of organic, inorganic, or polymeric substrates
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Prepares and presents technical data and recommendations at technical reviews.
- Writes validation protocols and reports applicable to new processes.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
- Oversees development builds associated with the project using special work requests.
- Develops qualified production lines.
- Provides Design for Manufacturability (DFM) input to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians and may train manufacturing personnel when required as part of a validation.
- May serve as core team member or extended team member on new product projects.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.
Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.
Planning and Organization
Plans, organizes, and prioritizes own daily work routine to meet established schedule.
Discretion/Latitude; Supervision Received; Decision Making
Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.
Business Relationships and Project Management
Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.
Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.
Provides guidance to less experienced staff.