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What attributes (i.e. - preferred qualifications) would make this candidate stand out?
The position is intended to primarily support manufacturing/process engineering activities, system configuration, and support (including DME and PLM), CPV activities, controlled documentation, and manufacturing process monitoring.
The candidate should have good analytical skills to evaluate manufacturing/process data and identify trends, but we are not looking for expertise in statistical modeling, machine learning, or advanced programming. Tools such as Excel, JMP, and Power BI would support the role rather than define it. Please revise the preferred qualifications to better reflect this focus.
Preferred Candidate Profile
Education / Background
• Bachelor’s degree in Engineering preferred, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
• Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
• Knowledge of manufacturing processes, equipment, devices, packaging, and/or process operations is considered a strong plus.
Technical Skills
• Experience supporting manufacturing process and operations in a GxP/GMP environment, with a solid understanding of process performance, equipment, and manufacturing workflows.
• Experience with manufacturing systems and processes such as DME, PLM, Change Control, MMP/MPP management, and Continuous Process Verification (CPV).
• Experience supporting controlled document and process changes, including document updates, coordination of reviews and approvals, implementation activities, and associated GMP documentation.
• Experience supporting Continuous Process Verification (CPV) activities, including process data review, evaluation of process performance and variability, identification of trends, preparation of periodic CPV reports and presentations, and escalation of potential process performance issues.
• Ability to interpret manufacturing and process data to support process monitoring, investigations, troubleshooting, and continuous improvement activities.
• Strong proficiency with Excel and experience with process data trending, analysis, and visualization tools such as JMP and/or Power BI.
• Ability to perform system configuration activities, including understanding business and process requirements, evaluating configuration needs, implementing, or supporting configuration changes, testing changes, documenting results, and troubleshooting system or process issues.
• Experience working with controlled documentation, data integrity requirements, and GMP systems, and change management processes.
• Familiarity with SQL for data querying, troubleshooting, data verification, and investigation of system or process-related issues is preferred.
• Familiarity with digital tools and automation solutions used to improve manufacturing workflows, reporting, process monitoring, or system activities is considered a plus.
• Familiarity with tools such as Smartsheet and/or Microsoft 365 solutions, Power BI, Power Query, Power Automate, SQL, or similar technologies is considered a plus.
• Knowledge of manufacturing processes, including equipment, devices, packaging, and/or process operations, is preferred.
• Experience supporting APR, CPV, process monitoring, manufacturing performance reporting, and/or continuous improvement activities is considered a strong plus.
General Skills
• Strong engineering, analytical and technical problem-solving skills, with the ability to evaluate manufacturing, process and system issues and identify practical solutions.
• Excellent written and verbal communication skills, with the ability to interact effectively across different communication and working styles.
• Fully bilingual in English and Spanish.
SUMMARY
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
FUNCTIONS
General:
1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.
* Other functions may be assigned
Design Engineering:
1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
EDUCATION
Master’s degree in Engineering and 2 years of Engineering experience OR Bachelor’s degree in Engineering & 4 years of Engineering experience
COMPETENCIES/SKILLS
1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
-Problem solving and applied engineering.
-Basic technical report writing
-Verbal communication
-Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas:
-Basic technical presentations o Personal Organization o Validation Protocol Writing
-Dealing with and managing changeo Technical (Equipment Specific)
-Analytical Problem Solvingo Computer Literacy
-Specialized equipment/process expertise
-In-depth knowledge of validation processes and requirements as applied to new equipment installations
-Interacts effectively with variety of communication and working styles
-Ability to independently determine when additional internal resources are required to solve problems
-Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
-Schedule developmento Facilitation
-Collaboration
-Basic project managemento Completion and follow-up
-Established expertise in at least 3 separate areas of engineering technology.
-Ability to independently determine when additional external resources are required to solve problems
-Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
-Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
-Working knowledge of financial analysis tools
-Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
-Negotiation, persuasion and facilitation
-Collaboration
-Project cost development
-Conflict Resolution
-Leadership and teambuilding
-Management of contractors and vendors
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
The position is intended to primarily support manufacturing/process engineering activities, system configuration, and support (including DME and PLM), CPV activities, controlled documentation, and manufacturing process monitoring.
The candidate should have good analytical skills to evaluate manufacturing/process data and identify trends, but we are not looking for expertise in statistical modeling, machine learning, or advanced programming. Tools such as Excel, JMP, and Power BI would support the role rather than define it. Please revise the preferred qualifications to better reflect this focus.
Preferred Candidate Profile
Education / Background
• Bachelor’s degree in Engineering preferred, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
• Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
• Knowledge of manufacturing processes, equipment, devices, packaging, and/or process operations is considered a strong plus.
Technical Skills
• Experience supporting manufacturing process and operations in a GxP/GMP environment, with a solid understanding of process performance, equipment, and manufacturing workflows.
• Experience with manufacturing systems and processes such as DME, PLM, Change Control, MMP/MPP management, and Continuous Process Verification (CPV).
• Experience supporting controlled document and process changes, including document updates, coordination of reviews and approvals, implementation activities, and associated GMP documentation.
• Experience supporting Continuous Process Verification (CPV) activities, including process data review, evaluation of process performance and variability, identification of trends, preparation of periodic CPV reports and presentations, and escalation of potential process performance issues.
• Ability to interpret manufacturing and process data to support process monitoring, investigations, troubleshooting, and continuous improvement activities.
• Strong proficiency with Excel and experience with process data trending, analysis, and visualization tools such as JMP and/or Power BI.
• Ability to perform system configuration activities, including understanding business and process requirements, evaluating configuration needs, implementing, or supporting configuration changes, testing changes, documenting results, and troubleshooting system or process issues.
• Experience working with controlled documentation, data integrity requirements, and GMP systems, and change management processes.
• Familiarity with SQL for data querying, troubleshooting, data verification, and investigation of system or process-related issues is preferred.
• Familiarity with digital tools and automation solutions used to improve manufacturing workflows, reporting, process monitoring, or system activities is considered a plus.
• Familiarity with tools such as Smartsheet and/or Microsoft 365 solutions, Power BI, Power Query, Power Automate, SQL, or similar technologies is considered a plus.
• Knowledge of manufacturing processes, including equipment, devices, packaging, and/or process operations, is preferred.
• Experience supporting APR, CPV, process monitoring, manufacturing performance reporting, and/or continuous improvement activities is considered a strong plus.
General Skills
• Strong engineering, analytical and technical problem-solving skills, with the ability to evaluate manufacturing, process and system issues and identify practical solutions.
• Excellent written and verbal communication skills, with the ability to interact effectively across different communication and working styles.
• Fully bilingual in English and Spanish.
SUMMARY
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
FUNCTIONS
General:
1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.
* Other functions may be assigned
Design Engineering:
1. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
2. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
3. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
4. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
5. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
EDUCATION
Master’s degree in Engineering and 2 years of Engineering experience OR Bachelor’s degree in Engineering & 4 years of Engineering experience
COMPETENCIES/SKILLS
1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
-Problem solving and applied engineering.
-Basic technical report writing
-Verbal communication
-Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas:
-Basic technical presentations o Personal Organization o Validation Protocol Writing
-Dealing with and managing changeo Technical (Equipment Specific)
-Analytical Problem Solvingo Computer Literacy
-Specialized equipment/process expertise
-In-depth knowledge of validation processes and requirements as applied to new equipment installations
-Interacts effectively with variety of communication and working styles
-Ability to independently determine when additional internal resources are required to solve problems
-Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
-Schedule developmento Facilitation
-Collaboration
-Basic project managemento Completion and follow-up
-Established expertise in at least 3 separate areas of engineering technology.
-Ability to independently determine when additional external resources are required to solve problems
-Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
-Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
-Working knowledge of financial analysis tools
-Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
-Negotiation, persuasion and facilitation
-Collaboration
-Project cost development
-Conflict Resolution
-Leadership and teambuilding
-Management of contractors and vendors
**Weil Group is proud to be an Equal Employment Opportunity Employer.**