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Senior Process Engineer

Senior Process Engineer

BioPharma Consulting JAD GroupJuncos, Juncos, PR
Hace 3 días
Tipo de contrato
  • Quick Apply
Descripción del trabajo

We are seeking a highly experienced and independent Senior Engineer to lead complex engineering projects, support capital initiatives, drive process optimization strategies, and resolve operational challenges within a GMP-regulated pharmaceutical or biotechnology environment. This role requires deep technical expertise, cross-functional collaboration, and the ability to manage diverse engineering activities from concept to implementation.

Key Responsibilities :

  • Independently lead system and equipment design, implementation, and troubleshooting activities.
  • Apply advanced engineering principles to resolve technical issues and improve production processes.
  • Support operational teams by developing solutions for equipment downtime and recurring failures.
  • Drive process improvements through data analysis, root cause investigations, and implementation of CAPAs.
  • Lead and / or support risk assessments, validations, and continuous improvement efforts (e.g., Kaizen events, critiques, VSMs).
  • Collaborate with cross-functional departments (manufacturing, quality, validation, utilities, facilities, etc.) to define requirements and implement engineering solutions.
  • Coordinate with consultants, architects, and engineering firms to develop and review design documentation.
  • Assist in the development of project budgets, schedules, and resource allocation.
  • Supervise and mentor junior engineers, associates, and technicians on engineering assignments.
  • Author, review, and approve engineering documentation, including :
  • URS, RD, DS, SOPs, Job Plans, P&IDs, maintenance packages, and validation protocols (FAT, SAT, IOQ, PQ).
  • Ensure accuracy and compliance with industry regulations and internal quality systems.
  • Support execution and lifecycle management of validation documentation and change controls.
  • Maintain equipment / system documentation through various electronic systems.

Competencies :

  • Analytical and critical thinking
  • Technical writing and validation protocol development
  • Strong organizational and prioritization skills
  • Cross-functional collaboration and facilitation
  • Leadership and team-building
  • Effective verbal and written communication
  • Contractor and vendor oversight
  • Ability to manage multiple complex projects concurrently
  • Requirements

    Preferred Qualifications :

  • Bachelor's Degree in Engineering with 4+ years of experience, OR
  • Master’s Degree in Engineering with 2+ years of experience, OR
  • Doctorate in Engineering
  • Preferred disciplines : Mechanical, Electrical, or Chemical Engineering
  • Demonstrated ability to lead large-scale projects and mentor technical teams
  • Proficient in technical writing, problem-solving, and project coordination
  • Systems & Tools Expertise (Preferred) :

  • CMMS (e.g., MAXIMO) – work order creation, approval, execution, and documentation
  • Electronic Document Management Systems (e.g., CDOCS, GDMS) – authoring, reviewing, approving documentation
  • Quality Management Systems – deviation, CAPA, and change control ownership
  • Experience with equipment commissioning, qualification, and lifecycle documentation
  • Benefits

  • 6 months contract
  • Administrative Shift
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    Engineer • Juncos, Juncos, PR