Sr. Project Engineer: Equipment, Facility & AutomationVEQTOR • Durham, NC, US
Sr. Project Engineer : Equipment, Facility & Automation
VEQTOR • Durham, NC, US
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job_description.job_card.job_descriptionContainment, Contamination and Integrity design review : facility, equipment and process considerations Data Integrity and Security Automation Alarm Management Single Use Technology Serve as a client representative for facility operational readiness projects in the key areas : Containment, Contamination & System Integrity Data Integrity and Security Automation Alarm Management Single Use Technology Equipment Reliability Oversee or support acceptance testing, commissioning, startup, and validation activities for equipment and automation systems Contribute to the selection and design of automation systems, while also providing hands-on support for testing and troubleshooting PLC / PCS platforms such as Siemens, Rockwell, and DeltaV Ensure compatibility with process conditions for instruments and controls Develop and review documentation including URS, FS, DS, test protocols, and validation reports. Ensure compliance with data integrity Review and assess contamination strategy for warehouse, DS and DP unit operations, material & personnel flows using VEQTOR and client's-based guidelines and procedures. Identify gaps and complete actions items Collaboration with cross-functional and global teams including QA, validation, engineering, manufacturing sciences and vendors Conduct regular system walk-downs and troubleshoot field issues Adhere to VEQTOR and client safety, documentation, and operational procedures Lead or support implementation of GxP computer systems , collaborating with internal engineering teams, external vendors, Quality Assurance (QA), and validation personnel to ensure compliance with industry regulations and project specifications. Lead or participate in Commissioning and Qualification (C&Q) activities , including the preparation and execution of Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, while ensuring traceability to specifications and regulatory requirements. Manage or assist in change control and impact assessments related to facility systems, automation platforms, equipment, and single-use technologies. Contribute to the preparation of technical documentation and rationale supporting change justifications, risk assessments, and validation impact. Develop and implement contamination control strategies in collaboration with QA, Facilities, and Operations teams. Ensure that cleanroom classifications, airflow design, materials flow, personnel practices, and cleaning procedures align with ISO 14644, EU Annex 1, PDA / ISPE standards throughout the project lifecycle. Coordinate closely with QA, Engineering, IT, and Operations to ensure alignment of automation and facility systems with site quality policies, safety procedures, and production goals. Demonstrate excellent interpersonal skills , including the ability to resolve conflicts using poise, diplomacy and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility and education levels Familiarity with design considerations for aseptic techniques, system integrity, containment, cleaning, sanitization / sterilization and data integrity considerations in the pharmaceutical and life sciences industries. Minimum 5+ years of relevant experience in engineering or automation roles within regulated environments; pharmaceutical or biotech experience preferred. Minimum of 7+ years of C&Q or 5 years of CAPEX commissioning experience Familiarity with clean utilities, facilities, and manufacturing systems Hands-on experience with at least 1 automation systems (PLC, SCADA, PCS) and their integration with equipment / utilities. Knowledge of current industry guidelines : ISPE Baseline Guides, GAMP, PDA, ASTM E2500. Detail oriented, self-motivated, and a collaborative team member Ability to thrive in a dynamic, fast-paced environment Developing problem solving and creative thinking skills, and interaction with upper management and design teams Understanding cGMPs, validation lifecycle, cleanroom design, data integrity & security requirement, biomanufacturing operations and sterile manufacturing Ability to work independently with structured supervision Strong interpersonal, organizational, writing and communication skills Commitment to upholding VEQTOR values, demonstrating honesty, integrity, pride, accountability, teamwork, and commitment.
Sr. Project Engineer : Equipment, Facility & Automation
Location : Raleigh–Durham–Holly Springs area, North Carolina
Hiring candidates both locally and from outside North Carolina. Relocation assistance is available.
Job Description :
VEQTOR is seeking a highly capable Sr. Project Engineer with strong design expertise in facility infrastructure, equipment and automation systems to support our client's CAPEX projects, and serves as a client representative during hand-off, as well as operational readiness. This role combines understanding of front-end design and engineering with the technical depth required to assess the fit of equipment and systems within cGMP-compliant facilities. The ideal engineer will drive and support projects from design, construction, commissioning / qualification, and handover.
Main Responsibilities :
- Support front-end engineering design (FEED) for capital projects involving facility expansions, equipment and utility system upgrades, and automation installations with emphasis on but not limited to :
Automation Infrastructure & Integration
Automation Infrastructure & Integration
Maintain communication with clients and internal leadership through status reporting
Description of Duties :
Perform other duties as assigned.
Required Qualifications :
J-18808-Ljbffr
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Sr Project Engineer • Durham, NC, US
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