Holly Springs, North Carolina, United States Hybrid / WFH Options
Amgen
a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries. Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software packages. More ❯
Durham, North Carolina, United States Hybrid / WFH Options
Eli Lilly and Company
Key Objectives/Deliverables: The Sr. Principal Associate - Quality and Regulatory Intelligence is responsible for: 1. Business Quality Assurance Assuring the computer systems are GMP classified appropriately, designed and operated in compliance with the Lilly Global QS standards and related documents. Acting as Subject Matter Expert on business requirements for More ❯
New Albany, Ohio, United States Hybrid / WFH Options
Amgen
for automation. Experience in supporting key manufacturing systems with 24x7 operations individually and with vendors. Experience or solid grasp of current GoodManufacturing Practices (GMP), 21CFR Part 11 regulations, change control, validation. Experience with Agile Product Development delivery and SAFe practices What you can expect from us As we work More ❯
Washington, Washington DC, United States Hybrid / WFH Options
Amgen
and how they relate to laboratory readiness and platform selection. Deep knowledge of laboratory operations, analytical testing, quality control workflows, and regulatory requirements (e.g., GMP, GLP, FDA, ISO standards). Proficiency in data science and analytics tools such as Python, R, SQL, or MATLAB. Experience with LIMS, MES, ELN, and More ❯
Indianapolis, Indiana, United States Hybrid / WFH Options
Eli Lilly and Company
Must develop a deep understanding of the Serialization solutions deployed to meet Lilly's global serialization strategy for packaging. Experience with GoodManufacturing Practices (GMP) and Computer System Validation (CSV) regulations, will be vital in ensuring documented processes and procedures meet the highest quality and compliance standards. Must have Strong More ❯
Stevenage, Hertfordshire, United Kingdom Hybrid / WFH Options
Jas Gujral
experience leading IT at a senior management level Track record of delivering results quickly Experience in delivering IT services to customers Work in a GMP or highly regulated environment Preferred Experience: Experience of agile product development Experience of Lean Six Sigma Infrastructure delivery (networking, hardware) to customers Experience with data More ❯
and process transfer expected to exceed 5 years. Prior experience with biopharmaceutical product registration preferably with FDA and/or EMEA. Knowledge of current GMP's, ICH Guidelines, and FDA/EU validation practices for biopharmaceutical processes required. Preferred Qualifications: If you have the following characteristics, it would be a More ❯
Indianapolis, Indiana, United States Hybrid / WFH Options
Eli Lilly and Company
platforms Experience working in a regulated industry Additional Skills/Preferences B.S. preferably in Chemical, Mechanical, Electrical, or Computer Engineering Experience in pharma or GMP industry Experience in commissioning and qualification Experience working with validated systems Expertise in Lilly's preferred platforms, including Rockwell Automation, Emerson DeltaV, Foxboro, and Microsoft More ❯
Indianapolis, Indiana, United States Hybrid / WFH Options
Eli Lilly and Company
and product data solutions Minimum Requirements: Bachelors degree or higher in science, engineering or related field Minimum of 5 years of experience in pharmaceutical GMP operations Additional Skills/Preferences: 5+ years experience in TSMS functions Strong understanding of central, network and site TSMS responsibilities and needs Experience with Lilly More ❯
Birmingham, Staffordshire, United Kingdom Hybrid / WFH Options
CTI Clinical Trial and Consulting Services
systems Bulk bio automation concepts CIP/SIP Clean utility generation and distribution Waste systems Aspects related to facility operations such as: Operating philosophies GMP Regulatory framework Aspects related to project delivery such as: Basis of design Basis of safety Simulation tools Tech Transfer Commissioning and Qualification Good experience of More ❯
Macclesfield, England, United Kingdom Hybrid / WFH Options
KBC Technologies Group
Supply chain planning and optimisation Source: Procurement of externally sourced materials and contract manufacturing Make: Manufacturing and quality release of medicines in a validated (GMP) environment Delivery The role will focus on the definition and governance of enterprise information architectures, strategies, designs, models and consolidating thinking and artefacts across Operations More ❯
Saint Paul, Minnesota, United States Hybrid / WFH Options
Solventum
in this role include: Experience in a regulated design environment with medical device development highly preferred, FDA or ISO registered work experience. Experience in GMP certified Manufacturing Processes and UL, IEC Standards. Experience with ARM based processors including Cortex M0, M4, and A series Experience with USB, RS-232, I2C More ❯
proactive with the ability to take ownership of tasks and drive them to completion Desirable: Good Experience in 3rd party tracking & analytics solutions, including GMP and Adobe Previous client-facing media agency experience Knowledge of running Google shopping campaigns Experience on retail media platforms such as Criteo and CitrusAd Benefits More ❯
New Albany, Ohio, United States Hybrid / WFH Options
Amgen
professional we seek will have these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of Information Systems job experience in a GMP environmen OR Bachelors degree and 4 years ofInformation Systems job experience in a GMP environmen OR Associates degree and 8 years of Information Systems job … experience in a GMP environment OR High school diploma/GED and 10 years of Information Systems job experience in a GMP environment Preferred Qualifications: BS or MS in computer science, engineering, information systems, or related field 5+ years experience designing, developing, deploying, and operating automated solutions across Cloud, On … for automation. Experience in supporting key manufacturing systems with 24x7 operations individually and with vendors. Experience or solid grasp of current GoodManufacturing Practices (GMP), 21CFR Part 11 regulations, change control, validation. Experience with Agile Product Development delivery and SAFe practices Methods and technologies to support Manufacturing Data integrations (e.g. More ❯
New Albany, Ohio, United States Hybrid / WFH Options
Amgen
professional we seek will have these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of Information Systems job experience in a GMP environment OR Bachelors degree and 4 years of Information Systems job experience in a GMP environment OR Associates degree and 8 years of Information Systems … job experience in a GMP environment OR High school diploma/GED and 10 years of Information Systems job experience in a GMP environment Preferred Qualifications: BS or MS in computer science, engineering, information systems, or related field Industry experience with software development of key manufacturing systems such as Supervisory … rapid pace Experience in supporting key manufacturing systems with 24x7 operations individually and with vendors Experience or solid grasp of current GoodManufacturing Practices (GMP), 21CFR Part 11 regulations, change control, validation. Experience with Agile Product Development delivery and SAFe practices Knowledge in Data Integrity and Security Comprehensive understanding of More ❯
vision for modernization in this space Ability to travel for customer meetings and presentations up to 40% Nice to Have Industry experience with QC, GMP quality content, training management, quality systems processes, or manufacturing Leadership of global Sales teams to drive opportunities with intensity Seasoned at developing and maintaining relationships More ❯
and converting opportunities into successful outcomes. Consult - give strategic support and guidance to clients, delivering high quality and forward-thinking solutions. Pension Projects - including GMP equalisation, data and administration. Propositions development - influence strategic plans for growth of the Operational Solutions business support. Drive innovation - contribute to new tools and technologies More ❯
New Albany, Ohio, United States Hybrid / WFH Options
Amgen
Operations Development at the Amgen Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio manufacturing facility. The position is expected to travel for approximately 25%. Based in New Albany … serve patients. The professional we seek will possess these qualifications. Basic Qualifications: Doctorate degree Or Masters degree & 2 years of engineering experience in a GMP environment Or Bachelors degree & 4 years of engineering experience in a GMP environment Or Associate degree & 8 years of engineering experience in a GMP environment … Or High school diploma/GED and 10 years of engineering experience in a GMP environment Preferred Qualifications: Advance degree in Computer, Electrical, Mechanical, Chemical Engineering, or Biomedical Engineering Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations Knowledge in More ❯
clearly at every level WHAT WE ARE LOOKING FOR Have extensive, relevant programmatic experience (Google Ads (Display/Video), DSPs (e.g. Adform, Tradedesk, DV360), GMP and Analytics) Have experience with, and gain a lot of energy from, guiding other people Have experience with the Dutch and/or Nordic publisher More ❯
Holly Springs, North Carolina, United States Hybrid / WFH Options
Amgen
automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand … in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering. Direct knowledge of BMS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software. Extensive understanding and background in programming, design, installation and lifecycle More ❯
Novato, California, United States Hybrid / WFH Options
BioMarin Pharmaceutical Inc
Support following the launch of PAS-X to our production environment in January of 2026 Participate in development and maintenance of the MES recipes GMP approval lifecycle documentation Contribute to process flow discussions and translate existing system functionality to future state processes Create and maintain MES recipes and master data …/recipes in coordination with Material Operations, Manufacturing, Automation and IM personnel as per defined escalation processes Create and maintain procedures pertaining to the GMP lifecycle of both recipes and master data Support new process transfers and equipment process changes Support MES training of SMEs and Users Support the management More ❯
San Diego, California, United States Hybrid / WFH Options
Avidity Biosciences
product to ensure robust development data packages for regulatory submissions. In addition, the Drug Product Process Development Engineer will support all aspects of non-GMP and GMP drug product development and manufacturing at external CMOs. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is … and/or within CMOs for scale-up of new or existing drug products. Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures. What We Seek BS in pharmaceutical sciences/engineering with at least 3 years relevant and hands on experience; Masters … in pharmaceutical sciences/engineering a plus. Strong understanding of drug product GMPmanufacturing and pharmaceutical unit operations required, along with understanding of US and EU regulations. Experience working with third-party CMOs preferred. Quality and attention to detail in documentation work and reports. Ability to multi-task, adapt to More ❯
Holmes Chapel, Cheshire, United Kingdom Hybrid / WFH Options
Bespak Limited
systems at our Holmes Chapel site. You'll provide hardware and software support, resolve breakdowns, implement preventative maintenance, and ensure compliance with GMP (GoodManufacturingPractice), EHS, and company standards. Your role also involves supporting computer system validation, quality improvement initiatives, and training other team members. This is a hands … and coding support to maintain system performance. Resolve equipment breakdowns and conduct root cause analysis. Support engineering CAPEX and improvement projects. Ensure compliance with GMP, EHS, and company standards. Support computer system validation and lifecycle management. Contribute to engineering best practices and project execution. Train team members on equipment, systems More ❯
Stockport, Greater Manchester, North West, United Kingdom Hybrid / WFH Options
Bespak
systems at our Holmes Chapel site. You'll provide hardware and software support, resolve breakdowns, implement preventative maintenance, and ensure compliance with GMP (GoodManufacturingPractice), EHS, and company standards. Your role also involves supporting computer system validation, quality improvement initiatives, and training other team members. This is a hands … and coding support to maintain system performance. Resolve equipment breakdowns and conduct root cause analysis. Support engineering CAPEX and improvement projects Ensure compliance with GMP, EHS, and company standards. Support computer system validation and lifecycle management. Contribute to engineering best practices and project execution. T rain team members on equipment More ❯
Stoke-On-Trent, Staffordshire, West Midlands, United Kingdom Hybrid / WFH Options
Bespak
systems at our Holmes Chapel site. You'll provide hardware and software support, resolve breakdowns, implement preventative maintenance, and ensure compliance with GMP (GoodManufacturingPractice), EHS, and company standards. Your role also involves supporting computer system validation, quality improvement initiatives, and training other team members. This is a hands … and coding support to maintain system performance. Resolve equipment breakdowns and conduct root cause analysis. Support engineering CAPEX and improvement projects Ensure compliance with GMP, EHS, and company standards. Support computer system validation and lifecycle management. Contribute to engineering best practices and project execution. T rain team members on equipment More ❯