Process Engineer
Brooksource, Concord, NC, United States
Overview
TITLE:
Process Engineer – Filling (Sterile Injectable Manufacturing)
LOCATION:
Concord, North Carolina (Onsite)
DURATION:
12-Months+
PAY:
Competitive (based on experience)
SHIFT:
Primarily Day Shift (Flexibility required for Afternoon/Evening shift during first 6–12 months)
ABOUT THE ROLE
Brooksource Engineering Services is supporting a pharmaceutical manufacturing partner in the buildout and operation of a state-of-the-art GMP sterile injectable facility in Concord, NC. We are seeking a Process Engineer to support aseptic filling operations within a highly automated manufacturing environment.
This role is responsible for the technical ownership, performance, and lifecycle management of critical filling equipment and processes. The ideal candidate will bring hands-on experience supporting aseptic production operations and a strong understanding of GMP-regulated manufacturing.
Safety, quality, and compliance are the highest priorities. This role plays a key part in ensuring reliable, compliant, and efficient manufacturing operations.
What you’ll do
Own the safe design, operation, and technical stewardship of aseptic filling equipment and systems
Serve as a core member of the process team, developing deep expertise in filling processes and equipment
Monitor, trend, and optimize process performance using control systems and data analysis tools
Lead complex troubleshooting efforts across equipment, process, and operational issues
Evaluate process changes for GMP impact and maintain compliance using change control, deviations, and investigations
Support or lead commissioning, qualification, and validation activities (IQ/OQ/PQ)
Drive CAPAs, continuous improvement initiatives, and periodic process reviews
Partner with maintenance, automation, and quality teams to ensure operational excellence
Provide technical guidance and oversight to maintenance and engineering technicians
What you bring
Bachelor’s degree in Engineering, Life Sciences, or a related field
1–3 years of experience in automated manufacturing or process engineering within a regulated environment
Strong understanding of GMP and sterile/aseptic manufacturing operations
Ability to troubleshoot complex systems and drive technical solutions
Strong communication and cross-functional collaboration skills
Willingness to work onsite and support an afternoon/evening shift during initial months
Preferred Experience
Hands-on aseptic production support experience (filling operations strongly preferred)
Experience with sterile injectable manufacturing processes
Exposure to automated filling lines and related technologies
Experience supporting validation and qualification activities (IQ/OQ/PQ)
Familiarity with deviation management, CAPAs, and change control systems
Physical & Work Requirements
Ability to work onsite in a GMP manufacturing environment
Flexibility to support off-shift hours (afternoon/evening) as needed
Ability to wear required PPE, including cleanroom gowning
Ability to stand, walk, and support operations for extended periods
Disclaimer
Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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TITLE:
Process Engineer – Filling (Sterile Injectable Manufacturing)
LOCATION:
Concord, North Carolina (Onsite)
DURATION:
12-Months+
PAY:
Competitive (based on experience)
SHIFT:
Primarily Day Shift (Flexibility required for Afternoon/Evening shift during first 6–12 months)
ABOUT THE ROLE
Brooksource Engineering Services is supporting a pharmaceutical manufacturing partner in the buildout and operation of a state-of-the-art GMP sterile injectable facility in Concord, NC. We are seeking a Process Engineer to support aseptic filling operations within a highly automated manufacturing environment.
This role is responsible for the technical ownership, performance, and lifecycle management of critical filling equipment and processes. The ideal candidate will bring hands-on experience supporting aseptic production operations and a strong understanding of GMP-regulated manufacturing.
Safety, quality, and compliance are the highest priorities. This role plays a key part in ensuring reliable, compliant, and efficient manufacturing operations.
What you’ll do
Own the safe design, operation, and technical stewardship of aseptic filling equipment and systems
Serve as a core member of the process team, developing deep expertise in filling processes and equipment
Monitor, trend, and optimize process performance using control systems and data analysis tools
Lead complex troubleshooting efforts across equipment, process, and operational issues
Evaluate process changes for GMP impact and maintain compliance using change control, deviations, and investigations
Support or lead commissioning, qualification, and validation activities (IQ/OQ/PQ)
Drive CAPAs, continuous improvement initiatives, and periodic process reviews
Partner with maintenance, automation, and quality teams to ensure operational excellence
Provide technical guidance and oversight to maintenance and engineering technicians
What you bring
Bachelor’s degree in Engineering, Life Sciences, or a related field
1–3 years of experience in automated manufacturing or process engineering within a regulated environment
Strong understanding of GMP and sterile/aseptic manufacturing operations
Ability to troubleshoot complex systems and drive technical solutions
Strong communication and cross-functional collaboration skills
Willingness to work onsite and support an afternoon/evening shift during initial months
Preferred Experience
Hands-on aseptic production support experience (filling operations strongly preferred)
Experience with sterile injectable manufacturing processes
Exposure to automated filling lines and related technologies
Experience supporting validation and qualification activities (IQ/OQ/PQ)
Familiarity with deviation management, CAPAs, and change control systems
Physical & Work Requirements
Ability to work onsite in a GMP manufacturing environment
Flexibility to support off-shift hours (afternoon/evening) as needed
Ability to wear required PPE, including cleanroom gowning
Ability to stand, walk, and support operations for extended periods
Disclaimer
Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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