VEQTOR
Sr. Project Engineer: Equipment, Facility & Automation
VEQTOR, Raleigh, North Carolina, United States, 27601
Sr. Project Engineer: Equipment, Facility & Automation
Location: Raleigh-Durham–Holly Springs area, NC; Chicago, IL. Relocation assistance is available; multiple locations. VEQTOR is seeking a Sr. Project Engineer with design expertise in facility infrastructure, equipment and automation systems to support CAPEX projects, serve as a client representative during hand-off and operational readiness. This role combines front-end design and engineering with the technical depth 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, to 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 containment, contamination and integrity design review, and data integrity and security. Serve as a client representative for facility operational readiness projects in data integrity and security. 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 (Siemens, Rockwell, DeltaV). Ensure compatibility of instruments and controls with process conditions. 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; identify gaps and complete action items per VEQTOR and client guidelines and procedures. Collaborate with cross-functional and global teams including QA, validation, engineering, manufacturing sciences and vendors. Conduct regular system walk-downs and troubleshoot field issues. Maintain communication with clients and internal leadership through status reporting. Adhere to VEQTOR and client safety, documentation, and operational procedures. Lead or support implementation of GxP computer systems; collaborate with internal and external stakeholders to ensure regulatory compliance. Lead or participate in Commissioning and Qualification activities (IQ, OQ, PQ) with traceability to specifications and regulatory requirements. Qualifications
Familiarity with aseptic design considerations, system integrity, containment, cleaning, sanitization/sterilization and data integrity in pharma/life sciences. Minimum 5+ years in engineering or automation roles within regulated environments; pharma/biotech experience preferred. Minimum 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 one automation system (PLC, SCADA, PCS) and integration with equipment/utilities. Knowledge of 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, and interaction with upper management and design teams. Understanding of cGMPs, validation lifecycle, cleanroom design, data integrity & security, biomanufacturing operations and sterile manufacturing. Ability to work independently with structured supervision. Strong interpersonal, organizational, writing and communication skills. Commitment to VEQTOR values: honesty, integrity, pride, accountability, teamwork, and commitment. Seniorities
Mid-Senior level Employment type
Full-time Job function
Engineering and Information Technology Industries
Professional Services Note: This description focuses on the Sr. Project Engineer role and removes boilerplate or unrelated postings for clarity.
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Location: Raleigh-Durham–Holly Springs area, NC; Chicago, IL. Relocation assistance is available; multiple locations. VEQTOR is seeking a Sr. Project Engineer with design expertise in facility infrastructure, equipment and automation systems to support CAPEX projects, serve as a client representative during hand-off and operational readiness. This role combines front-end design and engineering with the technical depth 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, to 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 containment, contamination and integrity design review, and data integrity and security. Serve as a client representative for facility operational readiness projects in data integrity and security. 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 (Siemens, Rockwell, DeltaV). Ensure compatibility of instruments and controls with process conditions. 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; identify gaps and complete action items per VEQTOR and client guidelines and procedures. Collaborate with cross-functional and global teams including QA, validation, engineering, manufacturing sciences and vendors. Conduct regular system walk-downs and troubleshoot field issues. Maintain communication with clients and internal leadership through status reporting. Adhere to VEQTOR and client safety, documentation, and operational procedures. Lead or support implementation of GxP computer systems; collaborate with internal and external stakeholders to ensure regulatory compliance. Lead or participate in Commissioning and Qualification activities (IQ, OQ, PQ) with traceability to specifications and regulatory requirements. Qualifications
Familiarity with aseptic design considerations, system integrity, containment, cleaning, sanitization/sterilization and data integrity in pharma/life sciences. Minimum 5+ years in engineering or automation roles within regulated environments; pharma/biotech experience preferred. Minimum 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 one automation system (PLC, SCADA, PCS) and integration with equipment/utilities. Knowledge of 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, and interaction with upper management and design teams. Understanding of cGMPs, validation lifecycle, cleanroom design, data integrity & security, biomanufacturing operations and sterile manufacturing. Ability to work independently with structured supervision. Strong interpersonal, organizational, writing and communication skills. Commitment to VEQTOR values: honesty, integrity, pride, accountability, teamwork, and commitment. Seniorities
Mid-Senior level Employment type
Full-time Job function
Engineering and Information Technology Industries
Professional Services Note: This description focuses on the Sr. Project Engineer role and removes boilerplate or unrelated postings for clarity.
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