Senior Process Engineer
Job Summary - a concise overview of the job
The Senior Process Engineer II independently performs various activities related to optimization and analysis of production processes, new products, processes and technology transfers. Coordinates resources from Engineering, R&D, Regulatory Affairs, QA, and Production personnel assigned to specific projects. Provides direction to engineers and technicians regarding project requirements. Develops and communicates project timelines and status. Assists in conducting efficiency studies and troubleshooting to manufacturing and packaging areas. Provides technical and specialized engineering support during facility construction and facility/equipment setups. This role will require a minimum of 50% travel both domestic and international.
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 within a multiple locations.
§ Make decisions that may require developing new options to solve a wide range of difficult problems.
§ Make decisions guided by policies and precedents in non-standard situations.
§ Work independently on assignments using knowledge and work experience. Recommend courses of action, consistently considering possible outcomes of decisions made. Work is reviewed and measured based on meeting objectives and schedules.
§ Manage personal activities to meet established department objectives, working within a time horizon of quarterly to six month objectives. Work is measured by output, meeting and achieving pre-defined Quarterly/Annual targets.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Prepare/execute engineering study and validation protocols for new and current products per SOPs/cGMPs.
§ Coordinate resources from Engineering, R&D, Regulatory Affairs, Quality Assurance, and Production personnel assigned to specific projects. Provide direction to engineers and technicians regarding project requirements. Develop and communicates project timelines and status.
§ May lead/mentor junior level staff.
§ Provide input into the development of budgets, schedules, and performance requirements.
Technical / Specialized Engineering
§ Provide technical and specialized engineering support during facility construction and facility/equipment Installations and qualifications.
Efficiency / Troubleshooting
§ Assist in conducting efficiency studies and troubleshooting to manufacturing and packaging areas.
§ Work on and solve increasingly complex projects/problems where analysis of situation or data requires evaluation of identifiable factors.
§ Write qualification protocols, SOPs, and reports for equipment to assure compliance in all manufacturing and support areas.
§ Act as advisor to teams/team members to meet schedules and/or resolve technical problems.
§ Frequently interact with supervisors, customers/vendors, and/or functional peer group managers. May interact with senior management. Interactions normally involve matters between functional areas, other company divisions or units.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ BS degree in Pharmaceutical or Engineering or related fiends, Chemical Engineering is preferred, with 7+ years’ related experience OR
§ MS with 5+ years’ experience as noted above OR
§ PhD with 2+ 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.
§ Extensive knowledge of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
§ Pharmaceutical solids manufacturing principles, practices and applications.
§ Analytical test methodology (BU, Assay, CU and dissolution profile, etc.)
§ Understanding of concepts of equipment qualification/calibration\.
§ Complete understanding of 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).
§ Contributes to the development of new concepts, techniques and approaches.
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.
§ Is able to write clearly and succinctly in a variety of communication settings and styles.
§ Writes clearly on both technical and non‐technical topics.
§ Able to provide routine technical guidance to junior Engineers.
§ Strong technical writing skills for complex reports and regulatory documents; ability to prepare all types of pharmaceutical documentation.
§ Ability to handle multiple projects, duties, assignments; ability to contribute in team environment.
§ Solving practical problems, considering variety of variables where only limited standardization exists.
§ Communicating clearly and concisely, both orally and in writing.
§ Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
§ Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
§ 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.
§ Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.
§ Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.
§ The noise level in the work environment is usually moderate.
§ Requires a minimum of 50% travel to both domestic and international destinations.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.