Senior Engineer ProQN956

ProQualityNetwork; Juncos (PR); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

ProQualityNetwork in Puerto Rico is seeking a Senior Engineer to lead process characterization, optimization, and troubleshooting within manufacturing, operations, pilot plant and capital project environments. The role focuses on equipment modifications, process improvements, validation activities, and complex technical assignments.

Candidates should have strong regulatory knowledge (GLP/GMP) and experience with packaging equipment and new equipment design, with bilingual English/Spanish

Formación

• Experience with pharmaceutical/biotech manufacturing environments.
• Knowledge of validation protocols and documentation.
• Understanding of GLP and GMP requirements.
• Experience documenting technical work and presenting results.
• Background in engineering project development and execution.

Responsabilidades

• Lead complex or novel engineering assignments and improve methodologies.
• Develop and enforce engineering standards and procedures affecting multiple units.
• Coordinate engineers, associates, and technicians across projects.
• Apply advanced engineering knowledge to address manufacturing challenges.
• Lead and mentor cross-functional teams on engineering initiatives.

Conocimientos

Pharmaceutical manufacturing

Validation processes

GLP/GMP

Technical reporting

Engineering problem-solving

Educación

Master's degree in Engineering

Bachelor's degree in Engineering

Descripción del empleo

Location: Juncos, Puerto Rico (Puerto Rico residents only)

Work Arrangement: Onsite

Work Schedule: Administrative Shift

Contract Duration: 7 Months

Number of Positions: 1

POSITION SUMMARY

Our client is seeking an experienced Senior Engineer to independently lead and support process characterization, optimization strategies, and troubleshooting of operational challenges within manufacturing, operations, pilot plant, and capital project environments.

The successful candidate will apply advanced engineering principles to the design, development, and implementation of equipment modifications, process improvements, validation activities, and engineering projects. This role requires the ability to manage complex technical assignments, coordinate cross-functional teams, and develop practical engineering solutions while ensuring compliance with applicable quality and regulatory requirements.

Candidates with experience in pharmaceutical or medical device manufacturing, particularly in packaging equipment, new equipment design, engineering projects, and validation, are strongly preferred.

PREFERRED QUALIFICATIONS

• Knowledge and experience with packaging equipment and manufacturing processes.
• Experience supporting the design, development, and implementation of new equipment and processes.
• Background in engineering project development and execution.
• Experience with equipment and process validation.
• Industry experience in pharmaceutical, biotechnology, or medical device manufacturing.
• Fully bilingual in English and Spanish.

KEY RESPONSIBILITIES

• Independently complete complex or novel engineering assignments requiring the development or improvement of engineering techniques, methodologies, and procedures.
• Develop engineering policies, standards, and procedures that may impact multiple organizational units.
• Coordinate, supervise, and review the work of engineers, associates, and technicians on individual projects and ongoing assignments.
• Apply advanced engineering techniques and specialized technical knowledge to address complex operational and manufacturing challenges.
• Apply engineering principles across multiple disciplines to support a broad range of technical assignments.
• Serve as a technical subject matter expert in at least one engineering discipline, providing direction on appropriate methodologies and solutions.
• Apply advanced engineering knowledge to project planning, execution, and technical decision-making.

Design Engineering and Project Execution

• Develop innovative technical solutions to complex engineering problems using sound engineering judgment, creativity, and analytical skills.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to establish requirements and recommendations for major equipment, system, and facility modifications.
• Partner with project managers to execute engineering and design projects within established schedules, budgets, and quality requirements.
• Coordinate consultants, architects, and engineering firms in the development of standardized engineering and design documentation.
• Develop and manage departmental or project budgets involving multiple engineering disciplines.
• Support equipment design, installation, modification, and validation activities.
• Identify technical challenges and determine when additional internal or external resources are required to achieve project objectives.
• Manage multiple engineering projects simultaneously, ensuring timely execution, follow-up, and completion.

EDUCATION AND EXPERIENCE

Candidates must meet one of the following educational and experience requirements:

• Master's degree with at least 2 years of engineering experience; OR
• Bachelor's degree in Engineering with at least 4 years of engineering experience.

REQUIRED COMPETENCIES AND SKILLS

Technical and Engineering Expertise

• Working knowledge of pharmaceutical and biotechnology manufacturing processes.
• Familiarity with validation processes, requirements, and execution methodologies.
• Comprehensive understanding of validation protocol execution and documentation requirements.
• Experience with technical documentation in highly regulated environments.
• Ability to interpret and apply Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Ability to apply engineering principles and scientific knowledge to manufacturing and production processes.
• Specialized equipment and process knowledge, including validation requirements for new equipment installations.
• Ability to develop solutions to technical problems of varying complexity and scope.
• Established expertise in at least three areas of engineering technology.
• Proficiency in technical report writing, validation protocol preparation, and technical presentations.
• Computer literacy and ability to operate specialized equipment and engineering-related systems.

Project Management and Leadership

• Experience in project planning, schedule development, coordination, and execution.
• Ability to manage project costs, budgets, and financial analysis activities.
• Ability to delegate responsibilities and coordinate the work of engineers, contractors, and vendors.
• Strong leadership, team-building, negotiation, facilitation, and conflict-resolution skills.
• Ability to manage competing priorities and multiple projects simultaneously.
• Strong organizational, follow-up, and completion skills.

Communication and Problem-Solving

• Advanced analytical and problem-solving skills, applying engineering theory, scientific principles, and calculations to develop effective solutions.
• Excellent verbal communication and collaboration skills.
• Ability to interact effectively with individuals and teams with different communication and working styles.
• Ability to independently assess technical challenges and determine when additional resources or specialized expertise are needed.
• Adaptability and the ability to manage changing project requirements.
• Strong collaboration and interpersonal skills when working with internal departments and external stakeholders.

Interested candidates must meet the educational and experience requirements and be available to work onsite in Juncos, Puerto Rico, on the administrative shift.