Process Engineer - CIP/ SIP/ Autoclave

Amgen Inc

Amgen seeks a Process Engineer to support design, commissioning, and qualification of CIP, SIP, and autoclave systems for a new advanced drug substance manufacturing facility in North Carolina. The role involves lifecycle technical support, regulatory compliance, and operational readiness across manufacturing systems.

Responsibilities

Support commissioning and qualification of CIP, SIP, and autoclave systems per GMP requirements
Provide technical expertise and lifecycle support for manufacturing equipment and associated automation
Interact with regulatory inspectors to demonstrate compliance of operating systems
Develop equipment maintenance programs and coordinate maintenance activities
Assist with new product introductions through engineering assessments and equipment modifications

Requirements

Master's degree OR Bachelor's degree with 2+ years engineering experience
Bachelor's degree in Chemical, Mechanical, or related engineering discipline (preferred)
3+ years relevant experience, including 2+ years in biopharmaceutical operations/manufacturing
Direct knowledge of GMP biopharmaceutical production equipment design and troubleshooting
Experience with CIP circuit design/validation, SIP systems, and autoclaves
Familiarity with regulated environments (cGMP, OSHA, EPA) and GMP quality systems
Data-driven problem-solving skills (Root Cause Analysis, Statistical Process Control, Six Sigma)

Apply

Vacancy posted 5 days ago

Similar jobs that could be interesting for youBased on the Process Engineer - CIP/ SIP/ Autoclave in Holly Springs, NC vacancy

Senior Process Engineer - CIP / SIP / Autoclaves
...company by 2027. SeniorProcessEngineer-CIP/SIP/Autoclave What youwill do In this vital... ...you will be joining the Facilities & Engineering (F&E) group to partner closely with... ...circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated...
Suggested
Work experience placement
Flexible hours
Shift work
Jobleads-US
Holly Springs, NC
2 days ago
Senior Process Engineer - CIP/SIP/Autoclaves
...Senior Process Engineer position supporting design, commissioning, and operational management of CIP, SIP, and autoclave systems at a new advanced drug substance manufacturing facility. Role involves lifecycle equipment support, troubleshooting, regulatory compliance,...
Suggested
Amgen
Holly Springs, NC
2 days ago
Senior Process Engineer - CIP/SIP & Autoclave Systems
...Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, focusing on CIP, SIP, and Autoclave systems for drug substance production. You will design, commission, and qualification activities, partnering with corporate engineering to ensure...
Suggested
Jobleads-US
Holly Springs, NC
2 days ago
CIP Process Engineer
...Job Description Job Description Technical Source is currently in search of a CIP Process Engineer for a greenfield pharmaceutical facility in the Raleigh-Durham-Chapel Hill Area. This is a long-term contract position that requires on-site work. The qualified candidate...
Suggested
Long term contract
Visa sponsorship
Technical Source
Holly Springs, NC
10 days ago
Senior Process Engineer
...Join to apply for the Senior Process Engineer role at BioSpace . Be among the first 25 applicants. At Amgen, if you... ...other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection,...
Suggested
Full time
Work experience placement
Local area
Flexible hours
BioSpace, Inc.
Holly Springs, NC
3 days ago
Validation Engineer I
...your career. VALIDATION ENGINEER I What you will do... ...landmarks related to results for autoclave performance qualification, cleaning... ...of manufacturing process equipment Supply cleaning... ...Purification, Clean Utilities, CIP, SIP, Production Services, and/or...
Flexible hours
Night shift
Initial Therapeutics, Inc.
Holly Springs, NC
1 day ago
Upstream Process Engineer
$60 - $70 per hour
...Piper Companies is seeking an Upstream Process Engineer to join a leading organization in the biotechnology manufacturing industry for a long-term contract opportunity in Holly Springs, North Carolina. The Upstream Process Engineer will provide hands‑on manufacturing...
Hourly pay
Long term contract
Piper Companies
Holly Springs, NC
1 day ago
Process Engineer
$130k - $155k
...Piper Companies is seeking a Process Engineer to join a leading biotechnology manufacturing organization. This Process Engineer will provide hands‑on support for upstream manufacturing operations with a strong focus on process equipment performance, production support...
ZP Group
Holly Springs, NC
1 day ago
Downstream Process Equipment Engineer
...Job Description Job Description Technical Source is currently in search of a Downstream Process Engineer for our pharmaceutical client in the Raleigh-Durham-Chapel Hill Area. This is a long-term contract position that requires on-site work. The qualified candidate...
Long term contract
Visa sponsorship
Technical Source
Holly Springs, NC
a month ago
Lead Process Engineer
$152.81k - $193.6k
...evaluate technical bid specifications for process and clean utility equipment; calculate... ...bottom up studies of utility, drain, and CIP systems to size equipment; support development... ...on weekly basis; lead team of process engineers; develop budget, schedule and list of deliverables...
Full time
Remote work
Jacobs
Cary, NC
3 days ago
Process Analytical Engineer
...This Process Analytical Engineer role supports Amgen's North Carolina manufacturing facility, focusing on qualification, calibration, and maintenance of laboratory systems for cGMP Quality Control operations. Responsibilities include troubleshooting analytical equipment...
Amgen
Holly Springs, NC
5 days ago
Senior Process Engineer
...Amgen seeks a Senior Process Engineer to join the Facilities & Engineering group at its advanced FleX Batch drug substance manufacturing facility in Holly Springs, North Carolina. The role involves designing, commissioning, and qualifying biopharmaceutical process equipment...
Work experience placement
Flexible hours
Amgen
Holly Springs, NC
a month ago
Microelectronics Ultrapure Water (UPW) Senior Process Engineer
...and energy. Together, we pursue a shared mission to create a more sustainable future.Job DescriptionAbout the RoleProcess Engineers on our Process Engineering team are key partners for customers in the North American market. As a creative technical leader, you'll support...
H1b
Immediate start
Flexible hours
Veolia Environnement
Cary, NC
2 days ago
6244 - CIP (Clean-in-Place) Engineer
$107.8k - $168.01k
...our collective expertise We are seeking a Clean-in-Place (CIP) Engineer with hands-on experience overseeing the commissioning and... ...Hands-on experience with CIP systems and automated cleaning processes ~ Strong understanding of CQV lifecycle documentation (IQ/OQ...
Temporary work
Work experience placement
Verista, Inc.
Apex, NC
22 days ago
Engineer, QA Drug Substance Manufacturing
...The Engineer, QA Drug Substance Manufacturing is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance...
Full time
Flexible hours
FUJIFILM Biotechnologies
Holly Springs, NC
11 hours ago
Water Distribution System Hydraulic Engineer
...sustainable infrastructure and our expertise in engineering, procurement, consulting and construction... ..., capital and life-cycle cost analyses, CIP prioritizationExperience with preparing... ...assistance completing the application process because of a disability, please contact...
Part time
Work experience placement
Work at office
Remote work
Visa sponsorship
Flexible hours
Black & Veatch
Cary, NC
2 days ago
Senior Electrical Engineer - Power Systems
...A senior electrical engineer for power systems will join Amgen's manufacturing facility in Holly Springs, supporting design, construction, and commissioning of electrical systems for process, utilities, and building infrastructure. The role involves collaborating with...
Amgen
Holly Springs, NC
5 days ago
Manufacturing Engineer
...Description The Manufacturing Engineer performs complex assignments often requiring development of new or improved products/processes/techniques. Responsible for performing standard engineering assignments usually representing a significant portion of a larger project...
Work at office
AAR
Apex, NC
1 day ago
Project Manager - Food and Beverage Process Engineering
...Job Description Job Description We are looking for a Project and Engineering Manager for our growing process engineering company. Our company is growing rapidly within the food and beverage industry and we need an experienced project and engineering manager. We work...
Temporary work
Work at office
Local area
DISRUPTIVE PROCESS SOLUTIONS LLC
Apex, NC
a month ago
Water Distribution System Hydraulic Engineer
...Veatch has an exciting opportunity for a Water System Hydraulic Engineer . In this role, you will have the opportunity to: Provide... ...& resiliency evaluations, capital and life-cycle cost analyses, CIP prioritization ~ Experience with preparing project...
Work experience placement
Work at office
Remote work
Flexible hours
Black & Veatch Family of Companies
Cary, NC
more than 2 months ago
Plastics Manufacturing Engineer
$65k - $75k
...Plastics Manufacturing Engineer Location: 34 Strohm Road, Shippensburg, PA, 17257, United States Base Pay: $65... ...competencies necessary to successfully lead teams and manage operational processes in a 24/7 manufacturing environment. Essential...
Rotational program
Full time
Traineeship
Internship
Work at office
Relocation
Shift work
Lane Enterprises
Holly Springs, NC
2 days ago
Associate Process Engineer - Cary, NC
...most progressive and innovative construction, automation and engineering firms. EAD supports clients' projects on hundreds of systems in... ...complexities! EAD Engineering is looking for an Associate Process Engineer for projects in industrial and processing facilities...
Work at office
Weekend work
Afternoon shift
EAD Management Services Inc
Cary, NC
29 days ago
Product Validation Engineer
$65k - $80k
...RFA Engineering ( is an engineering service provider dedicated to delivering our clients with timely engineering support and expertise.... ...engineering staff using state-of-the-art engineering tools & processes. This position will operate onsite at our customer's world-class...
Full time
Temporary work
Work at office
Flexible hours
RFA Engineering
Fuquay Varina, NC
2 days ago
Network Automation Engineer
...Network Engineer - Network Automation & Infrastructure Preferred Education: Bachelor's degree in Computer Science, Information Technology, or a related field (or equivalent experience) Required Skills, Experience & Abilities: ~5+ years of network engineering...
Rose International
Apex, NC
4 days ago
Electrical Engineer - Nuclear Power
$103.99k - $219.36k
...innovation in sustainable infrastructure and our expertise in engineering, procurement, consulting and construction, together we are building... ...problemsTypically assists with performance management process, mentoring, recognition, and any corrective actions required....
Part time
Work experience placement
Work at office
Local area
Relocation
Visa sponsorship
Flexible hours
Black & Veatch
Cary, NC
3 days ago
Senior Manufacturing Systems Engineer: Automation PLC
...Senior Manufacturing Systems Engineer needed to lead automation technical initiatives for a new drug substance manufacturing facility... ...integrating multiple platforms with Emerson DeltaV Collaborate with process experts to translate manufacturing requirements into automated...
Amgen
Holly Springs, NC
5 days ago
Manufacturing Systems Engineer: Automation
...Amgen seeks a Manufacturing Systems Engineer to develop and maintain process control systems for a new advanced drug substance manufacturing facility. The role involves designing automation solutions, supporting system validation in a GMP environment, and driving continuous...
Amgen
Holly Springs, NC
5 days ago
Senior Manufacturing Systems Engineer: Automation - DeltaV
...Senior Manufacturing Systems Engineer role providing automation technical leadership for a new advanced drug substance manufacturing facility. Responsibilities include developing and maintaining process control systems on Emerson DeltaV, collaborating with subject matter...
Work experience placement
Amgen
Holly Springs, NC
5 days ago
Sr Engineer 1, Process Validation
...The Senior Engineer or Scientist of Process Validation ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing, executing, and...
Full time
FUJIFILM Biotechnologies
Holly Springs, NC
2 days ago
Downstream CQV Engineer
...Job Summary We are seeking experienced Downstream CQV Engineers to support a large-scale biopharmaceutical manufacturing project in... ...environment . ~ Experience with Construction-to-CQV turnover processes. ~ Hands-on experience with Mechanical Completion (MC/MCC)...
Full time
United Pharma
Holly Springs, NC
2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Process Engineer - CIP/ SIP/ Autoclave. Be the first to apply!