Clinical Process Specialist
Completes advanced engineering projects with peer input and guidance from engineering management to increase yield, maximize capacity, reduce costs, and decrease process variability, while maintaining regulatory compliance. A specialist on complex technical and business matters. Work is highly independent.
Essential Duties & Responsibilities
• Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.
• Receives general project direction. Responsible for project progress.
• Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
• Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.
• Identifies opportunities, develops insights, stimulates new ideas, and implements process improvements in collaboration with manufacturing, engineering, other essential internal partners, and external partners including vendors and project contract support.
• Assists with technically challenging process deviations and their resolution.
• Provides direct support to all commercial pharmaceutical manufacturing and support operations by supplying direct technical expertise and advanced statistical concepts e.g. DOE with focus on process capability and reliability.
• Provide direct project management support including planning, securing funding, technical support to Validation Coordinator, and oversight and guidance to project support organizations.
• Participate in start-up efforts of new equipment, software, or processes.
• Implement changes using GMP change control and validation processes.
• Previewing/providing feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc.
• Collaborate with center functions on product development initiatives.
• Work on special projects as they arise
Knowledge, Skills & Qualifications
• Has mastered best practices. Has an advanced understanding of engineering discipline
• Can assess what work supports the product strategy and make insightful recommendations regarding priorities
• Expert in your domain of expertise. Familiar in other areas of domain expertise within the team.
• Must be at least 18 years of age
Physical Requirements and Work Environment
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment with occasional work performed in a clean room environment