Senior Engineer - Manufacturing & Capital Projects

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 95,000 - 135,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks an experienced engineer to independently provide and direct characterization of process optimization strategies and troubleshoot operational issues in manufacturing, pilot plant, or capital project environments. Applies advanced engineering principles to design and implement major system modifications and projects.

Responsibilities include developing analyses, presenting interpretations, collaborating with QA, validation, and manufacturing teams to define

Qualifications

• Experience with pharmaceutical/biotech manufacturing environments and validated processes.
• Experience with maintaining documentation in regulated environments and compliance with GLPs/GMPs.
• Ability to interpret and apply validation protocols and write technical reports.

Responsibilities

• Provide and supervise complex engineering assignments requiring new techniques and procedures.
• Develop and implement major system modifications in manufacturing or capital projects.
• Collaborate with research, manufacturing, utilities, QA, and validation to define requirements for large complex modifications.
• Manage budgets, schedules, and contractor coordination.

Skills

Pharma processes

Validation processes

GLP/GMP knowledge

Engineering design

Project management

Cross-functional collaboration

Documentation

Analytical problem solving

Communication

Vendor management

Budgeting

Leadership

Education

Doctorate

Master’s + 2 years experience

Bachelors + 4 years experience

Tools

CMMS

Validation tools

Job description

Independently provides and/or directs the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital project environments. Applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and process/capital projects. Develops, organizes, analyzes, and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Functions

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that impact multiple organizational units.
• Supervise, coordinate, and review work of engineers, associates, and technicians on an ongoing and project basis.
• Employ advanced engineering techniques and modifications of advanced techniques within area of expertise.
• Apply engineering principles outside primary discipline to a broad variety of related assignments.
• Serve as a peer-recognized engineering technology specialist in at least one area, with responsibility for determining methodologies.
• Apply mature engineering knowledge in planning and conducting projects.
• Other functions may be assigned.
• Develop technical solutions to complex problems requiring ingenuity and creativity.
• Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation to define requirements and recommendations for large or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
• Coordinate work of consultants, architects, and engineering firms in developing standard design documents.
• Develop departmental or project budgets encompassing multiple disciplines.

Skills

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Familiarity with documentation in highly regulated environments.
• Ability to operate specialized laboratory equipment and computers.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Ability to develop solutions to routine technical problems of limited scope.
• Problem solving and applied engineering.
• Basic technical report writing.
• Strong verbal communication.
• Comprehensive understanding of validation protocol execution requirements.
• Technical presentations, personal organization, validation protocol writing.
• Managing change; equipment-specif\u00efc technical expertise.
• Analytical problem solving; computer literacy.
• Specialized equipment/process expertise.
• In-depth knowledge of validation processes for new equipment installations.
• Ability to interact effectively with diverse communication and working styles.
• Ability to determine when additional internal resources are required.
• Ability to manage multiple projects simultaneously.
• Schedule development, facilitation, collaboration.
• Basic project management, completion, and follow-up.
• Expertise in at least three engineering technology areas.
• Ability to determine when external resources are required.
• Ability to solve moderate to highly complex technical problems using scientific and engineering theory.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage project work of others.
• Negotiation, persuasion, facilitation.
• Conflict resolution, leadership, team building.
• Management of contractors and vendors.

• Doctorate OR
• Master’s + 2 years of Engineering experience OR
• Bachelor’s in Engineering + 4 years of Engineering experience.

Preferred Qualifications

• Experience with manufacturing equipment ownership in CMMS systems (work order approval/closure, PM strategy, spare parts definition/accuracy/updates).
• Reliability assessments and change control requirements.
• Collaborate with Engineering staff to ensure optimal maintenance strategies for manufacturing equipment.
• Enhance system reliability focusing on equipment availability, downtime reduction, and maintenance optimization.
• Develop equipment performance metrics (availability, downtime, etc.) and identify improvement opportunities.
• Lead implementation of equipment improvement projects.
• SME for systems regarding design, maintenance, and compliance operations.
• Support equipment troubleshooting within functional area or technical expertise.
• Support deviation processes; define, implement, and own CAPAs related to equipment within area of expertise.
• Drive Environmental, Health, and Safety compliance within the organization.

• Shift: 7:30am - 4:30pm
• 1- year contract with possible extension