Sr. Engineer

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc. is seeking an experienced engineering professional to support manufacturing equipment in a regulated pharma/biotech environment.

You will independently manage technical assessments, investigations, and CAPA actions to improve equipment reliability and process efficiency. Responsibilities include coordinating with Manufacturing, Quality, and Validation teams, managing Maximo work orders, and developing preventive maintenance strategies and SOPs.

Qualifications

• Experience supporting manufacturing equipment in a regulated pharma/biotech setting.
• Ability to independently manage technical assessments, CAPA and equipment improvement actions.
• Familiarity with validation activities and documentation in a highly regulated environment.
• Experience with interpreting GLPs and GMPs and applying them to equipment
• Proven ability to coordinate with Manufacturing, Quality, Automation, Validation, and suppliers.

Responsibilities

• Perform System Owner assessments and engineering impact assessments related to equipment failures and quality events.
• Support technical investigations, identify failure mechanisms, and develop corrective actions to reduce recurrence.
• Evaluate CAPA applicability to other equipment and areas.
• Manage engineering activities in IBM Maximo including work order reviews and maintenance coordination.
• Develop and revise preventive maintenance strategies, Job Plans, and SOPs.
• Coordinate with internal teams and suppliers to drive equipment modernization projects.
• Prepare clear technical reports with traceable documentation and deadlines.
• Assist with troubleshooting, repairs, and obsolescence replacement of equipment.

Skills

Pharma/biotech processes

Validation processes

Documentation in regulated environment

GLPs and GMPs knowledge

Engineering problem solving

Interdisciplinary collaboration

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Tools

IBM Maximo

Job description

What attributes (i.e. - preferred qualifications) would make this candidate stand out? The ideal candidate will have experience supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment, with the ability to independently manage technical assessments, corrective actions, and equipment improvement initiatives.

• Performing System Owner assessments and engineering impact assessments related to equipment failures, process deviations, and quality events.
• Supporting technical investigations, identifying equipment failure mechanisms, and developing corrective and preventive actions to reduce recurrence.
• Evaluating the applicability of CAPA and lessons learned to other equipment, systems, and manufacturing areas.
• Managing engineering activities in IBM Maximo, including work order technical review, pre-approval and post-approval activities, maintenance coordination, and follow-up through closure.
• Developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.
• Implementing engineering controls and completing actions associated with safety incidents and INCA records.
• Supporting equipment troubleshooting, repair coordination, replacement of obsolete equipment, spare parts evaluations, and equipment modernization projects.
• Working with biopharmaceutical manufacturing equipment such as centrifuges, autoclaves, process tanks, chromatography and UF/DF systems, homogenizers, filter integrity testers, and associated instrumentation.
• Preparing clear technical reports and assessment rationales, maintaining traceable supporting documentation, and completing actions within established deadlines.
• Coordinating with Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers.
• Managing multiple concurrent assignments and prioritizing work according to safety, quality, and operational needs..

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.