Utilities Engineer

Insight Global; Holly Springs (NC); On-site; USD 125,000 - 130,000; Full time

Job summary

An established industry player is seeking a Sr. Utilities Engineer to join their Facilities & Engineering team. In this pivotal role, you will collaborate with corporate engineering to design and qualify new systems essential for drug substance production. Your expertise in biopharmaceutical operations will be crucial as you lead improvements, develop maintenance programs, and ensure compliance with GMP standards. This opportunity offers a chance to make a significant impact in a dynamic environment dedicated to advancing pharmaceutical manufacturing. Join a team where your skills will help shape the future of healthcare.

Qualifications

• 6+ years of experience in Biopharmaceutical operations/manufacturing.
• Direct knowledge of GMP equipment and systems.

Responsibilities

• Provide system ownership for Biopharmaceutical process equipment.
• Develop equipment maintenance programs and ensure system safety.
• Support new product introductions and perform engineering assessments.

Skills

Problem Solving

Data Analytics

Root Cause Analysis (RCA)

Statistical Process Control (SPC)

Six Sigma

Predictive Maintenance

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Mechanical Engineering

Tools

GMP Biopharmaceutical Production equipment

autoclaves

clean in place (CIP) systems

washers

clean steam systems

water for injection systems

Job description

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$125,000.00/yr - $130,000.00/yr

Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/ systems needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation

Day to Day:

Our client is looking for a Sr. Utilities Engineer to join their team in Raleigh-Durham NC. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.

• Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
• Ensure systems are installed and operating safely and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• System guidance to identify performance risks and implement risk reduction strategies.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Manufacturing

Industries

Pharmaceutical Manufacturing