PharmEng Technology · 1 day ago
Capital Projects Engineer
Andover, MA
Contract
Onsite
Mid LevelPharmEng Technology is seeking a highly qualified Capital Projects Engineer to support a strategic initiative within the Capital Projects group at a major biopharmaceutical facility. This role involves managing project design activities, coordinating engineering deliverables, and ensuring compliance with regulatory requirements in a GMP environment.
ConsultingInformation TechnologyPharmaceutical
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
Qualification
Required
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
Company
PharmEng Technology
PharmEng Technology is a pharmaceutical company that provides consultancy services.
Founded in 1997
201-500 employees
H1B Sponsorship
PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Alan Kwong
Managing Director & CEO
Company data provided by crunchbase