Process Analytical Engineer — cGMP Lab Systems Lead
Initial Therapeutics, Inc.
Amgen in Holly Springs, North Carolina, is looking for a Process Analytical Engineer to plan and execute QA lab systems qualification. Key responsibilities include troubleshooting, regulatory compliance, and managing instrument validation. The ideal candidate will hold a Bachelor's degree in engineering and have experience in cGMP environments. This role offers the chance to contribute to our mission of serving patients and advancing your engineering career. Join Amgen's innovative team and be part of a leading biotech company committed to sustainability and patient care. #J-18808-Ljbffr Initial Therapeutics, Inc.
- ...‑neutral company by 2027. Process Analytical Engineer What you will do In this vital... ...maintenance of laboratory systems for cGMP Quality Control laboratory... ...for analytical equipment. Lead or work with teams in... ...Integrity Assessments for lab systems. Support Amgen’s laboratory...SuggestedLocal areaFlexible hoursNight shift
- Amgen Inc. (IR) is hiring a Process Analytical Engineer to join the Facilities & Engineering group in Holly Springs, NC. You will be responsible for maintaining and qualifying laboratory systems, troubleshooting analytical equipment, and ensuring regulatory compliance....Suggested
- CSL in Holly Springs, North Carolina is seeking a Process Engineer II to provide full-spectrum process engineering ownership for cGMP utility systems. Responsibilities include troubleshooting, change management, and capital projects support to ensure compliant utility operations...Suggested
$115.49k - $156.26k
...Career Category Engineering Job Description... ...Electrical Engineer - Power Systems What you will do... ...electrical perspective of process, utilities, and building... ...investigations. ~ Lead identifying and implementing... ...of regulations (e.g. cGMP, building codes, fire...SuggestedLocal areaFlexible hours- Position Summary The Process Engineer II provides full-spectrum process engineering ownership for cGMP utility systems. Responsibilities include in-field... ...& Operations Support Lead hands‑on troubleshooting of... ...Excellent problem‑solving and analytical skills Effective written...Suggested
- ...neutral company by 2027. Senior Process Engineer - Solution Prep, Upstream,... ...and qualify new equipment and systems needed for drug substance... ...process equipment as applicable. Lead identifying and implementing... ...regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity...Work experience placementLocal areaFlexible hoursShift work
- ...carbon‑neutral company by 2027. Process Engineer - Solution Prep, Upstream,... ...qualify new equipment and systems needed for drug substance... ...techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA),... ...environment (e.g., cGMP, OSHA, EPA, etc.) and familiarity...Work experience placementLocal areaFlexible hoursShift work
$88.28k - $119.44k
Process Engineer - Solution Prep, Upstream, and Downstream Responsibilities... ...qualify new equipment and systems needed for drug substance production... ...experience (e.g., data analytics, root‑cause analysis, SPC,... ...in a regulated environment (cGMP, OSHA, EPA) and familiarity...Work experience placementShift work- ...ecosystem alignment with business needs and support manufacturing systems. You will manage Aveva PI Data Historian activities,... ...Responsibilities include managing relationships with stakeholders and leading multiple technology initiatives. #J-18808-Ljbffr Initial Therapeutics...
- ...Position Overview The Lead Tech of Instrumentation... ...Manufacturing Practices (cGMP), and Occupational... ...reduce costs and improve processes, and lead projects to implement... ...maintenance, and engineering, to ensure I&C activities... ...Maintenance Management System (CMMS). Experience with...Night shift
- Sargent Lundy is seeking an experienced electrical engineer in Cary, North Carolina, to join their project team focused on nuclear power plant electrical systems. This role includes preparing and reviewing engineering design packages, conducting calculations, and interfacing...
$136.91k - $185.23k
...Senior Manufacturing Systems Engineer: Automation - DeltaV (... ...becoming one of the world’s leading biotechnology... ...team to deliver robust process automation systems to... ...different platforms, analytical problem-solving techniques... ...Procedures (SOP) and cGMP documents.* Be constantly...Remote workWorldwideMonday to FridayFlexible hoursAfternoon shift- Manufacturing Systems Engineer: Automation You will work with a group of automation engineers responsible... ...: Develop and maintain the process control system on Emerson DeltaV distributed... ...Standard Operating Procedures (SOP) and cGMP documents. Be constantly curious and feed...Remote workFlexible hoursShift work
- Senior Manufacturing Systems Engineer As a Senior Manufacturing Systems Engineer... ...Develop and maintain the process control system on Emerson... ...Controls, CAPAs, and Deviations. Lead and support functional area... ...Operating Procedures (SOP) and cGMP documents. Be constantly...Remote workFlexible hoursShift workDay shift
- Senior Manufacturing Systems Engineer: Automation What you will... ...to deliver robust process automation systems to... ...different platforms, analytical problem‑solving techniques... ...CAPAs, and Deviations. Lead and support functional... ...Procedures (SOP) and cGMP documents. Be...Local area
- About the Role Arcadis is seeking a Process Engineer - Upstream Manufacturing to support large‑scale biologics production at its Holly Springs... ...experience with upstream cell culture operations (mammalian systems preferred), media and buffer preparation, inoculation and...Full timePart timeRelocation
- Amgen in Holly Springs is looking for a Process Engineer to support drug substance production by designing, building, and qualifying systems. The role involves ensuring GMP compliance and developing maintenance programs. Candidates should have relevant engineering experience...
- Job Summary As a Process Engineer you will be managing projects that result in a safer work environment, a higher quality product, a more efficient... ...and supporting new processes, new equipment and new assembly systems. Key Skills Process Engineer, Capital Projects, Equipment,...
- ...Inc. in Holly Springs, NC is looking for a Senior Process Engineer specializing in Solution Prep, Upstream, and Downstream... ...engineering excellence by designing manufacturing systems, ensuring regulatory compliance, and leading cross-functional collaborations. A Doctorate or...
- ...Gameplay Designer to join their dynamic team in Cary, North Carolina. You will be responsible for designing and implementing gameplay systems, including combat mechanics, and working collaboratively with multidisciplinary teams to enhance player experience. The ideal...
$148.72k - $201.2k
Career Category Engineering Job Description Join... ...7. Senior Manager Process Engineering Downstream... ...engineering team, lead technical projects... ...new equipment and systems needed for drug... ...environment (e.g. cGMP, OSHA, EPA, etc.),... ...Ability to apply analytical skills to evaluate...Full timeWork experience placementLocal areaFlexible hours- ...customer service tickets to ensure timely and accurate responses. Process returns, exchanges, refunds, and replacement orders.... ...entry, order modifications, and account maintenance within company systems. Coordinate with the sales team to ensure customer needs are addressed...Seasonal workFlexible hours
- Amgen Inc. (IR) in Holly Springs is seeking a Senior Electrical Engineer to join the Facilities & Engineering group. This role involves... ...standards, and supporting the commissioning and validation of systems. The ideal candidate will have a Bachelor's degree in Engineering...
- ...store management, including all required systems start-ups, required cash handling, and ensuring... ...work with warehouse and vendor ordering process as the orders are created, reviewed, and... .... Job ID: 1832098BR Title: Shift Lead Company Indicator: Walgreens...Hourly payWork experience placementSeasonal workWork at officeLocal areaFlexible hoursShift work
- ...Blueprint (Role Profile) The B Shift lead is accountable for productive and efficient... ...Implement efficient distribution center processes to reduce cost and lead time and to help... ...metrics updates on area boards Process system transactions for reporting and...Monday to FridayShift work
- FUJIFILM Biotechnologies in Holly Springs, North Carolina, seeks a Supervisor for the All QC team. This role involves supervising laboratory activities, ensuring compliance with testing standards, and managing a 24x7 team to support urgent manufacturing testing and sampling...
- Position Overview The Automation Engineer 3, DSM Upstream, will provide support... ...implementing changes to the Automation systems, updating design documents,... ...delivery of DeltaV logic for Upstream process areas, including Inoculum Lab, Media Preparation, Seed Culture, Large...
- A leading consulting firm, 3key Consulting, Inc., is seeking a Process Engineer for a biopharmaceutical client in North Carolina. The role involves designing and owning equipment, ensuring safety compliance, and optimizing manufacturing processes in a dynamic GMP environment...
- ...qualification efforts. Act as a process subject matter expert (SME) to... ...initiate, or support quality system records, including change... ...Improvement (CI) activities. Lead and participate in projects... ...~ BioWorks or BTEC Capstone cGMP coursework preferred What...Full timeShift work
- A leading engineering firm in Cary, North Carolina, is seeking a Staff Mechanical Engineer. This role requires expertise in mechanical design, managing equipment specifications, and leading projects. The ideal candidate will have a B.S. Degree in Chemical or Mechanical...
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