VetJobs
Senior Engineer (Site Mechanical Engineer) - Holly Springs, NC
VetJobs, Holly Springs, North Carolina, United States, 27540
Overview
Senior Engineer (Site Mechanical Engineer) – Holly Springs, NC. Lead technical owner for building mechanical systems supporting a large bio-pharmaceutical manufacturing site, focusing on HVAC/R, controlled temperature storage facilities, Life Safety Gas Detection systems, HEPA filter certification programs, and related mechanical utility systems. Ensure safe and reliable daily operation in accordance with established guidelines and procedures. Responsibilities
Site Design, Construction, Start-up, and Operational Readiness: provide system ownership during capital project execution for building mechanical, HVAC/R, Life Safety Gas Detection systems, and subsystems. Collaborate with capital project teams to ensure designs, installations, and operations are safe and compliant with environmental, health/safety practices, regulations, Amgen procedures, and standards. Support FAT/SAT activities; assist with installation, commissioning, and qualification of mechanical and HVAC systems; coordinate with QBAS (OEM), ETA, site engineers, and third parties to meet user requirements. Lead third-party contractors during startup, installation check-out, and air system balancing; verify equipment layout and maintenance access during construction. Develop SOPs and maintenance practices for mechanical and HVAC systems; implement master maintenance plans (MMP) and manage spare parts inventory for reliability. Provide ongoing system ownership for site mechanical/HVAC operation and maintenance; drive continuous improvement projects to enhance reliability, safety, and efficiency. Maintain drawings, schedules, zoning diagrams, and operating procedures; coordinate with electrical system owner for electrical readiness and outages related to mechanical/HVAC systems. Ensure readiness for internal and external audits related to Mechanical/HVAC systems; share best engineering practices with Amgen network sites. Troubleshoot and calibrate mechanical measurement and instrumentation (validated humidity, temperature, room differential pressure monitoring, life safety gas detection); maintain room pressurization strategies and documentation for GMP spaces. Own HEPA/ULPA filter certification programs, unidirectional booths, biosafety cabinets, and fume hoods testing/certification. Recommend facility changes affecting mechanical/HVAC systems and support project implementation; manage lifecycle of systems with Global Lifecycle Asset Management (SLCM); coordinate with OEMs and service providers for maintenance. Provide rotational on-call support and ensure 24x7 reliability of Mechanical/HVAC systems for plant operations. Minimum Education Required
High School/GED Job Category
Engineering What we expect of you
Strong communication skills; ability to work independently, manage multiple tasks in project settings, and collaborate effectively. Qualifications
Basic Qualifications: High school diploma / GED and 10 years of Maintenance or Engineering experience OR Associate’s degree and 8 years OR Bachelor’s degree and 4 years OR Master’s degree and 2 years OR Doctorate degree. Preferred Qualifications: Bachelor’s Degree in Engineering or related field; 6+ years in engineering or maintenance in biotech/pharma/medical device; 5+ years in a regulated environment; familiarity with GMP quality systems; strong understanding of utilities and HVAC systems; experience with asset management systems and building automation; CEM certification is desirable. What you can expect of us
Amgen offers competitive benefits, Total Rewards Plans aligned with local industry standards, and a collaborative culture. We are an Equal Opportunity employer and provide reasonable accommodations to applicants with disabilities. Job location: Holly Springs, NC. Salary range: 119,195.00 USD - 147,867.00 USD; additional salary information may be provided depending on the role and location. Additional details
City: Holly Springs, North Carolina; Job Code: Pharmaceutical; Affiliate Sponsor: Amgen.
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Senior Engineer (Site Mechanical Engineer) – Holly Springs, NC. Lead technical owner for building mechanical systems supporting a large bio-pharmaceutical manufacturing site, focusing on HVAC/R, controlled temperature storage facilities, Life Safety Gas Detection systems, HEPA filter certification programs, and related mechanical utility systems. Ensure safe and reliable daily operation in accordance with established guidelines and procedures. Responsibilities
Site Design, Construction, Start-up, and Operational Readiness: provide system ownership during capital project execution for building mechanical, HVAC/R, Life Safety Gas Detection systems, and subsystems. Collaborate with capital project teams to ensure designs, installations, and operations are safe and compliant with environmental, health/safety practices, regulations, Amgen procedures, and standards. Support FAT/SAT activities; assist with installation, commissioning, and qualification of mechanical and HVAC systems; coordinate with QBAS (OEM), ETA, site engineers, and third parties to meet user requirements. Lead third-party contractors during startup, installation check-out, and air system balancing; verify equipment layout and maintenance access during construction. Develop SOPs and maintenance practices for mechanical and HVAC systems; implement master maintenance plans (MMP) and manage spare parts inventory for reliability. Provide ongoing system ownership for site mechanical/HVAC operation and maintenance; drive continuous improvement projects to enhance reliability, safety, and efficiency. Maintain drawings, schedules, zoning diagrams, and operating procedures; coordinate with electrical system owner for electrical readiness and outages related to mechanical/HVAC systems. Ensure readiness for internal and external audits related to Mechanical/HVAC systems; share best engineering practices with Amgen network sites. Troubleshoot and calibrate mechanical measurement and instrumentation (validated humidity, temperature, room differential pressure monitoring, life safety gas detection); maintain room pressurization strategies and documentation for GMP spaces. Own HEPA/ULPA filter certification programs, unidirectional booths, biosafety cabinets, and fume hoods testing/certification. Recommend facility changes affecting mechanical/HVAC systems and support project implementation; manage lifecycle of systems with Global Lifecycle Asset Management (SLCM); coordinate with OEMs and service providers for maintenance. Provide rotational on-call support and ensure 24x7 reliability of Mechanical/HVAC systems for plant operations. Minimum Education Required
High School/GED Job Category
Engineering What we expect of you
Strong communication skills; ability to work independently, manage multiple tasks in project settings, and collaborate effectively. Qualifications
Basic Qualifications: High school diploma / GED and 10 years of Maintenance or Engineering experience OR Associate’s degree and 8 years OR Bachelor’s degree and 4 years OR Master’s degree and 2 years OR Doctorate degree. Preferred Qualifications: Bachelor’s Degree in Engineering or related field; 6+ years in engineering or maintenance in biotech/pharma/medical device; 5+ years in a regulated environment; familiarity with GMP quality systems; strong understanding of utilities and HVAC systems; experience with asset management systems and building automation; CEM certification is desirable. What you can expect of us
Amgen offers competitive benefits, Total Rewards Plans aligned with local industry standards, and a collaborative culture. We are an Equal Opportunity employer and provide reasonable accommodations to applicants with disabilities. Job location: Holly Springs, NC. Salary range: 119,195.00 USD - 147,867.00 USD; additional salary information may be provided depending on the role and location. Additional details
City: Holly Springs, North Carolina; Job Code: Pharmaceutical; Affiliate Sponsor: Amgen.
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