Sr. Engineer Drug Process Development

2 weeks ago


Ireland Amgen Inc. (IR) Full time

Sr. Engineer Drug Process Development page is loaded Sr. Engineer Drug Process Development Apply remote type Flex Commuter / Hybrid locations Ireland - Dun Laoghaire time type Full time posted on Posted 3 Days Ago job requisition id R-187386 Career Category Process Development Job Description

Job Posting Title Sr Engineer - Drug Process Development

Career Category Process Development

Employee Subgroup TBC

Country (State/Region) Ireland

Location (City) Ireland - ADL

Amgen Job Description 

The Sr Engineer provides process development technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global Process Development organization. The input provided will include support of process performance and implementation of process improvement strategies:

• Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug product lyophilization as well as formulation, filtration and filling vials/syringes/devices for parenteral products.

• Develops and characterizes drug product lyophilization processes and transfer technology to commercial drug product sites.

• Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.

• Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.

• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.

• Identifies and implements operational opportunities for current and new sterile operations.

• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.

Basic Qualifications

• Bachelors degree & 8 years of directly related experience OR

• Masters degree & 6 years of directly related experience OR

• Knowledge of aseptic manufacturing technologies and cGMPs

Preferred Qualifications

• Masters / PhD in a related Science or Engineering discipline

• 10+ years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Process Characterization or Tech Transfer (to commercial DP sites).

• Experience in lyophilization process development or tech transfer of lyophilization process to commercial scale.

• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability.

• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.

• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.

. Similar Jobs (1) Sr. Engineer - System Owner - 12 month FTC remote type On Site locations Ireland - Dun Laoghaire time type Full time posted on Posted Today

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

#J-18808-Ljbffr
  • Sr. Director

    2 days ago


    Ireland eli lilly and company Full time

    Sr. Director - Global Regulatory Scientist – Early Clinical Development page is loaded Sr. Director - Global Regulatory Scientist – Early Clinical Development Apply locations Ireland, Cork time type Full time posted on Posted 4 Days Ago job requisition id R-62024 At Lilly, we unite caring with discovery to make life better for people around the...


  • Ireland Amgen Inc. (IR) Full time

    Sr. Manager Engineering Projects page is loaded Sr. Manager Engineering Projects Apply remote type On Site locations Ireland - Dun Laoghaire Netherlands - Breda time type Full time posted on Posted 3 Days Ago job requisition id R-187325 Career Category Engineering Job Description Title Engineering Projects Sr Mgr L6 – reports to Director...

  • Process Engineer

    2 weeks ago


    Ireland Asset Recruitment Full time

    ref. 01158 Process Engineer (Technical Transfer) Our client, a leading multi-national Biotech company, is seeking enthusiastic candidates to join their External Manufacturing (ExM) Technical Operation team in two different sites, one located in Co. Louth – Ireland and one in Lucerne – Switzerland for Process Engineer (Technical Transfer) roles . As part...


  • Ireland Eli Lilly and Company Full time

    Sr. Laboratory Analyst (Sr. Specialist-Analytical) page is loaded Sr. Laboratory Analyst (Sr. Specialist-Analytical) Apply locations Ireland, Kinsale time type Full time posted on Posted Yesterday job requisition id R-64878 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader...


  • Ireland Allegion Canada Inc. Full time

    Associate Sr. Firmware Engineer page is loaded Associate Sr. Firmware Engineer Apply locations Bangalore, India time type Full time posted on Posted 10 Days Ago job requisition id JR28637 Creating Peace of Mind by Pioneering Safety and Security At Allegion, we help keep the people you know and love safe and secure where they live, work and visit. With...


  • Ireland eli lilly and company Full time

    Director / Sr. Director - Chorus Clinical Research Physician page is loaded Director / Sr. Director - Chorus Clinical Research Physician Apply locations Ireland, Cork time type Full time posted on Posted Yesterday job requisition id R-60040 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global...


  • Ireland Amgen Inc. (IR) Full time

    Manufacturing Process Technnician - Inspeciton - FTC page is loaded Manufacturing Process Technnician - Inspeciton - FTC Apply remote type On Site locations Ireland - Dublin time type Full time posted on Posted Yesterday job requisition id R-184712 Career Category Manufacturing Job Description Job Description Job Description Summary The...

  • Process Engineer

    5 days ago


    Ireland Asset Recruitment Full time

    ref 01109 Process Engineer – Upstream/Downstream Process Role Provide technical expertise in Upstream/Downstream processing to offer support to the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. The successful candidate will be responsible for ensuring that manufacturing processes are validated and maintained...


  • Ireland CrowdStrike Holdings, Inc. Full time

    Sr. Cloud Engineer, Cloud Security Product Group (Remote, IRE) page is loaded Sr. Cloud Engineer, Cloud Security Product Group (Remote, IRE) Apply locations Ireland - Remote time type Full time posted on Posted Yesterday job requisition id R18514 #WeAreCrowdStrike and our mission is to stop breaches. As a global leader in cybersecurity, our team changed...


  • Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Process Engineer

    6 days ago


    Ireland Joynes & Hunt Full time

    Process Engineer Location: Shannon, Ireland Our client is a gene therapy company that works with gene therapy discovery, development and GMP manufacturing. They have headquarters in London and the USA and have recently redesigned exciting new labs with cutting edge technology and the ability to work to a higher standard and increase their capacity of...

  • Process Engineer

    6 days ago


    Ireland Arcon Recruitment Services Full time

    Process engineer required for client in Ballina Co.Mayo Apply a proactive and methodical approach to troubleshooting daily shift operation issues and continuous improvement with cross functional teams, comprised of operations shift managers, technicians, engineers, quality, and safety. Perform detailed, technical breakdown analysis of improvements (losses...


  • Ireland Unispace Full time

    ROLE We are seeking a proactive Lead Process Engineer to join our growing Unispace Life Sciences team. This role is based out of our Centre of Excellence for Life Sciences, based in Mahon, Cork. This person will be joining our process engineering team, focused on delivery successful process-lead design projects for multiple clients. The successful...

  • Process Engineer

    2 days ago


    Ireland Penspen Ltd Full time

    Process Engineer - Cork - Ireland Permanent Full Time Circa Euro 65000 (Negotiable) with exceptional flexible benefits package. Must have right to work in Ireland Penspen have an exciting opportunity for an experienced Process Engineer based in Cork, Ireland. You will have experience in the Oil & Gas industry, anything from Offshore to...

  • R&D Staff Engineer

    5 days ago


    Ireland EPM Scientific - Phaidon International Full time

    The role of Senior Staff Engineer takes on a hands-on, customer facing, technical leadership role on a cross functional project core team guiding the design, development, verification and validation of on-body combination products in support, this role will give the opportunity to develop user-centric on-body drug delivery solutions designed to drive...


  • Ireland eli lilly and company Full time

    Associate / Senior Associate - Clinical Central Services & innovation page is loaded Associate / Senior Associate - Clinical Central Services & innovation Apply locations Ireland, Cork time type Full time posted on Posted Yesterday job requisition id R-63259 At Lilly, we unite caring with discovery to make life better for people around the world. We are...

  • Process Engineer

    11 hours ago


    Ireland Macro Plastics, Inc. Full time

    IPL is a global leading sustainable packaging solutions provider that manufactures specialty rigid packaging products used in the food, consumer, agricultural, logistics and environmental markets. We have over 2,500 colleagues in 18 manufacturing facilities, one corporate office and two R&D facilities across Canada, the U.S., Ireland, the U.K., Belgium and...


  • Ireland AstraZeneca GmbH Full time

    This is what you will do: The Senior Specialist Technical Services has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at Alexion’s facility in Blanchardstown, Dublin. The Senior Technical Specialist will provide processing expertise to support the technology transfer, validation and routine commercial...


  • Ireland SQA Services Full time

    If you have an eye for detail and want to help assure quality and facility qualifying and monitoring supply chain’s via audits in the animal health, pharmaceutical and similar regulated environments space, then this is the role for you! We have upcoming projects in the United Kingdom and the European Union in 2024, 2025 and beyond! We're looking for...


  • Ireland TiVo Corporation Full time

    Engineer - Audio Quality Assurance (with Python) Xperi invents, develops and delivers technologies that create extraordinary experiences at home and on the go for millions of people around the world. Powering billions of consumer electronics, connected cars and digital content titles, we make entertainment more immersive, driving more intelligent and every...