The Process Engineer I, with guidance, performs various duties related to optimization and analysis of production processes, new products, processes and technology transfers. Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products. Perform or assist on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
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 single location.
- Make decisions within guidelines and policies.
- Follow established procedures to perform assignments, with general instructions on the process and desired outcome.
- Work is reviewed for soundness of technical judgment and accuracy.
- Work is measured by output, meeting and achieving pre-defined monthly/quarterly targets.
Validation Protocols
- Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.
- Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.
25%
Technical Transfer
- Perform or assist on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
20%
Formulation Development
- Conduct or assist formulation development and evaluation for marketed and new products.
20%
Troubleshooting
- Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
- Conduct or support investigations on deviations.
- Evaluate and troubleshoot basic to mid-level manufacturing / packaging equipment and process issues.
- Work on problems of basic to moderate scope. Follow established practices and procedures in analyzing situations or data from which answers can be readily obtained.
20%
Training
- Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.
15%
Teamwork
- Interact daily with team members and/or functional peer groups, other teams/depts.
- May conduct presentations of technical information.
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- BS degree in Engineering or Chemical Engineering preferred with 3+ years’ related experience OR
- MS with 1+ year of relevant experience as noted above.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Working knowledgeable of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
- Working knowledge of Pharmaceutical manufacturing principles, practices and applications.
- Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).
- Understanding of concepts of equipment qualification/calibration.
- Understanding of computer validation concepts.
- Basic/Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
- Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
- Develops knowledge of principles and concepts of other disciplines.
- Understands the fundamental business drivers for the company.
Skills & Abilities
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 for the technical community and can construct logical arguments well.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
- Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
- 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.
- Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
- 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 Requirements
- 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.