Location
Boston, MA | United States
Job description
Location: Boston, MA
Department:Azzur Consulting LLC
Job Description
Azzur consultants are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. As a Project Engineer at Azzur Group, you will play a pivotal role in the successful execution and management of customer corporate CAPEX (Capital Expenditure) and site-specific OPEX (Operational Expenditure) projects of medium to high complexity in the Life Sciences industry. The ideal candidate will have a minimum of 2 years of experience, demonstrating a proven track record in delivering projects on time and within scope. This role requires a detail-oriented and results-driven professional with a passion for excellence in project execution. The following is a short list of the typical responsibilities and deliverables of any given project.
- Execute and assist in the management of customer corporate CAPEX and site-specific OPEX projects, ensuring adherence to project timelines, budgets, and quality standards.
- Work closely with internal and external stakeholders, including clients, project teams, and vendors, to understand project requirements and expectations.
- Proactively identify and mitigate project risks and issues, implementing corrective actions as needed.
- Develop and execute change control documents to manage alterations effectively, ensuring alignment with project objectives.
- Develop design specifications, including User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS) to guide project development.
- Conduct Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to validate the functionality and compliance of systems and equipment.
- Develop and execute thorough commissioning test protocols to ensure the successful integration and functionality of systems.
- Review and comprehend various construction drawings, including Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and architectural, mechanical, and electrical drawings.
- Draft Standard Operating Procedures (SOPs) pertaining to the operation, maintenance, and calibration of equipment, utilities, and facilities.
- Collaborate in supporting Failure Modes and Effects Analysis (FMEAs) on equipment and utility systems, contributing to risk assessment and mitigation strategies.
Qualifications
- BS in Engineering, Science or equivalent technical degree.
- Minimum of 2 years of experience in project engineering within the pharmaceutical and/or medical device industry.
- Proven track record of successfully managing projects of medium to high complexity.
- Strong project management skills, including the ability to create and execute detailed project plans.
- Solid understanding of GMP regulations and industry standards.
- Experience in executing validation protocols and generating thorough documentation.
- Strong analytical and problem-solving skills with attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a dynamic team environment.
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