Principal Process Engineer
Direct Reports (list)
Reports to (title)
Mgr, Pharmaceutical Technology
To be completed by Corporate Compensation:
Job Summary - a concise overview of the job
The Principal Process Engineer will assist in the design, optimization and analysis of production processes. Ensures all new products, processes and technology transfers are in a validated state as required for commercial manufacturing. Develop and execute strategies for technology transfers, process/packaging and cleaning validation and scale-ups. Lead and direct Managers, Specialists and Scientists within Technical Operations.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
- Process Engineering duties primarily for a single location.
- Make decisions by identifying new options and/or multiple solutions to complex problems and provides solutions that are innovative and ingenious.
- Work is performed without appreciable direction. Independently and consistently considers possible outcomes of decisions made. Work is reviewed and measured based on meeting objectives and schedules.
- Established developer and implementer of strategic objectives working within a six month to one year plus time horizon, focusing on Quarterly objectives. Work is measured by output, meeting current years’ budget and achieving pre-defined targets.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Production & Technological Optimization
- Analyze process improvement concepts to determine potential cost savings and determine process plan to fully assess the idea/concept.
- Consider all aspects of product life-cycle which may be impacted by process improvements, understanding potential cost savings and/or potential cost increases.
- Analyze real time and historical data gathered.
- Prepare formal report and/or presentation that summarize analysis results, outcomes and recommendations to management.
- Coordinate and effectively communicate status of projects with other departments.
- Assist in developing and administering budgets, schedules, and performance requirements.
- Direct/support the creation of appropriate databases to analyze data.
- Learn and apply new techniques for data analysis.
Teamwork & Coaching
- Coach team members to solve increasingly complex projects/problems where analysis of situation or data requires evaluation of identifiable factors.
- Act as advisor to teams, other departments and company to meet schedules and/or resolve technical problems.
- Regularly interact with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- BS degree in Engineering or Chemical Engineering preferred with 10+ years’ related experience OR
- MS with 8+ years’ experience as noted above OR
- PhD with 5+ years’ experience as noted above.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Advanced knowledge of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
- Pharmaceutical manufacturing principles, practices and applications.
- Analytical test methodology (BU, Assay, CU and dissolution profile, etc.)
- Understanding of concepts of equipment qualification/calibration.
- Pharmaceutical raw material tests (BD, TD, PSA, LOD, etc.) and raw material characterization.
- Understanding of computer validation concepts.
- Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
- Process improvement and scale up for complex products.
- Process/cleaning validation and technical transfer for manufacturing processes.
- Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
- Has advanced knowledge of principles, concepts, and theories of a discipline, & applies this advanced knowledge to the development of new concepts and principles.
- Has extensive knowledge of principles and concepts in related disciplines.
- Typically recognized as an expert in the organization.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Ability to change the thinking of, or gain acceptance of, others in sensitive situations and drive in the organization within current location and potentially other divisions or subsidiaries when necessary.
- Is able to write clearly and succinctly in a variety of communication settings and styles.
- Writes clearly on both technical and non‐technical topics.
- Ability to define problems, collect data, establish facts, and draw valid conclusions and deal with several abstract and concrete variables.
- Ability to plan and manage multiple projects simultaneously.
- Excellent communication skills including the ability to speak clearly and persuasively in positive or negative situations; listen and gain clarification; respond to questions; demonstrate effective presentation skills; and write clearly and informatively.
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs work flows and procedures.
- Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
- Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
- Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Occasionally lift and/or move up to 25 pounds.
- Occasional exposure to fumes or airborne particles.
- The noise level in the work environment is usually moderate.