Capital Projects Engineer

Capital Projects Engineer (12-Month Assignment Onsite)
Location: Andover, Massachusetts
Employment Type: Contract (12 Months, Full-Time, Onsite)
Industry: Biopharmaceutical Manufacturing

We are seeking a highly qualified Capital Projects Engineer to support a strategic, year-long initiative within the Capital Projects group at a major biopharmaceutical facility located in Andover, MA. This role offers significant exposure to site-level capital project planning and execution, with direct responsibility for key elements of design, validation, and implementation in a regulated GMP environment.

Position Summary

The Capital Projects Engineer will report to the assigned Capital Project Manager and will be responsible for managing project design activities, coordinating engineering deliverables, and ensuring compliance with internal quality systems and applicable regulatory requirements. The selected candidate will play a critical role in supporting project execution across various phases of capital investments, from initial scope development through commissioning and qualification.

Key Responsibilities

• Serve as the engineering lead for assigned capital projects, managing the design process in collaboration with architectural/engineering (AE) firms and equipment vendors.

• Oversee the development, review, and approval of engineering submittals and ensure adherence to project requirements and specifications.

• Own and manage Change Controls from initiation through closure, including resource assignment and execution.

• Conduct project risk assessments and support root cause analysis for any deviations or issues that arise during the project lifecycle.

• Manage the development of User Requirement Specifications (URS) and update Standard Operating Procedures (SOPs) as needed.

• Develop and execute validation deliverables (IQ, OQ, PQ) for all equipment installations, ensuring alignment with 21 CFR Part 11 and internal validation protocols.

• Coordinate training efforts between equipment suppliers and internal end users to ensure successful knowledge transfer and operational readiness.

Qualifications

• Bachelors degree in Engineering or a related technical discipline is required.

• Demonstrated experience in process engineering and equipment validation within a regulated biopharmaceutical or GMP manufacturing environment.

• Expertise in equipment validation requirements in accordance with 21 CFR Part 11.

• Strong understanding of GMP regulations, capital project execution, and cross-functional collaboration.

• Exceptional organizational, communication, and problem-solving skills with a commitment to quality and compliance.

This is an excellent opportunity for an experienced engineer to contribute to the successful delivery of critical capital initiatives in a leading-edge pharmaceutical environment.

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