Sr. Engineer

Weil Group, Inc; Juncos (PR); On-site; USD 120,000 - 170,000; Full time

Job summary

Weil Group, Inc is seeking a Sr. Engineer to lead complex projects, mentor engineers, and shape the technical roadmap in a regulated manufacturing environment.

You will apply advanced engineering principles to design modifications and drive reliability, optimization, and compliance with GMP/GLP standards, with the opportunity to make a global impact.

Qualifications

• Master’s degree in engineering with 2 years’ experience or Bachelor’s degree with 4 years’ experience.
• Experience in pharma/biotech processes.
• Knowledge of validation protocols (GLPs/GMPs).
• Ability to lead and mentor engineers in a fast-paced environment.

Responsibilities

• Lead engineering projects from concept through deployment in a regulated manufacturing setting.
• Develop and implement design modifications for large, complex systems.
• Collaborate with cross-functional teams to ensure project success and compliance.
• Mentor engineers and technicians, supervising staff on projects.
• Drive equipment reliability improvements and CAPA execution.

Skills

Pharma processes

Validation processes

Documentation in regulated env

Specialized lab equipment

GLPs/GMPs

Engineering production

Problem solving

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Tools

CMMS (Work orders)

Job description

We are looking for a visionary Sr. Engineer to lead complex projects, mentor top-tier talent, and drive our technical roadmap. If you thrive in a fast-paced environment and want your code to make a tangible, global impact, this is your place.

What attributes (i.e. - preferred qualifications) would make this candidate stand out?

• Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
• Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
• Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization
• Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
• Lead the implementation of equipment improvements projects
• SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.
• Support equipment troubleshooting within the functional area or in the scope of technical expertise.
• Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization

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

Demonstrated skills in the following areas

• 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.**