Senior Process Validation & Engineering Lead

Validation & Engineering Group; Juncos (PR); On-site; USD 110,000 - 180,000; Full time

Job summary

Validation & Engineering Group is a leading services supplier for the pharmaceutical, biotech, chemical, and medical devices industries. The role involves independent characterization of process optimization strategies, troubleshooting operations, and applying engineering principles to major system modifications.

Responsibilities include developing engineering policies, supervising a small team, and coordinating with project managers to meet schedule and budget constraints in regulated

Qualifications

• Doctorate or Master's degree with relevant engineering experience; alternatively a Bachelor's with substantial engineering experience.
• Familiarity with pharmaceutical/biotech processes and validation in a regulated environment.
• Ability to lead complex engineering projects, write technical documents and develop standards.

Responsibilities

• Develop and implement engineering policies and procedures across multiple units.
• Supervise and coordinate engineers, associates and technicians on projects.
• Apply advanced engineering techniques to complex system modifications and capital projects.
• Collaborate with research, manufacturing, process development and QA to define design requirements.
• Develop budgets for projects and ensure timely, on-budget delivery.
• Lead design documents and coordinate consultants and external firms.

Skills

Engineering leadership

Project management

Validation processes

GLPs GMPs knowledge

Communication

Education

Doctorate degree

Master’s degree + 3 years experience

Bachelor’s degree + 5 years experience

Tools

Process simulation software

Job description

Validation & Engineering Group is a leading services supplier for the pharmaceutical, biotech, chemical, and medical devices industries. The role involves independent characterization of process optimization strategies, troubleshooting operations, and applying engineering principles to major system modifications.

Responsibilities include developing engineering policies, supervising a small team, and coordinating with project managers to meet schedule and budget constraints in regulated