LIVE, WIN, THRIVE At Amgen, your ideas are the first step. We're on a continued goal of transforming biotech to better understand human diseases and how to fight them. Here's what it takes: The courage to dive into the challenges most won't and never forgetting who relies on our success. With our combined perspectives, we can build a better world for patients. Join us and discover purpose through your career.
Role: Process Engineer – Drug Product Sterile Fill / Finish
LIVE What you will do As a member of our team, you will play a crucial role in successfully transferring Commercial and Clinical Drug Product (DP) biologics into the Amgen Waterford site. The role requires a solid technical background for an Engineer who is a good collaborator and communicator, capable of working to achieve key milestones for DP Tech Transfer programs. Your expertise will contribute to Amgen Waterford site priorities and enable the strategic growth of the site's portfolio.
The position is responsible for facilitating technology transfer and operational readiness of biologic products being introduced into the Amgen Waterford site.
This is an onsite role position, actively working with various product teams.
Responsibilities: Provide process engineering support to Sterile Fill Finish product teams and projectsPerform gap analysis, facility fit assessments, process gap assessments and risk analysis for new product introductions.Drive development of new manufacturing processes and technologiesOwner of tech transfer-related documents e.g., Tech Transfer Plans/Protocols/Procedures/Manufacturing Batch Records.Lead defining and measuring critical process parameters, process capability analysis and deviation monitoringProvide manufacturing operations technical support and issue resolution.Define and review equipment specifications and associated test documentation.Support project through FAT, SAT and IOQ as neededStrong focus on disciplined root cause analysisLiaise with vendors on single-use technologies and integration into the processMonitor process risk and ensure mitigations are in place as requiredBenchmark other industries and organizations to ensure best practice is in use.Be active in the network, attending conferences/training seminars as neededBe part of our team We are a team of agile, out-of-the-box thinkers who are inspired to do more because we know we are part of something bigger. Striving to build meaningful careers at a company whose values we share because when we live up to our potential, we help patients live up to theirs.
WIN What we expect of you To excel in this role, you should possess the following qualifications and skills:
Educational Background: Bachelor's Degree in a relevant field (i.e. Chemical, Mechanical, Industrial, Electrical Engineering)Master's Degree (Optional but Beneficial) in engineering or a related field.Skills Considered Important: Strong analytical and problem-solving skills, with the ability to apply engineering principles and techniques to optimize processes and systems.Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams and interact with internal and external stakeholders.Proficient in using various software tools and applications, such as Microsoft Office, AutoCAD, MATLAB, and Aspen Plus.Knowledge of current industry standards and best practices, as well as relevant regulatory requirements and guidelines.Self-motivated, proactive, and adaptable, with the ability to manage multiple projects and prioritize tasks in a fast-paced environment.Compliance with the Health, Safety and Environmental policy and associated procedures.Take ownership of quality compliance in all activities under the responsibility of the role.Professional Experience: With 7 - 10+ years of Process Engineering / Technical Services / Technical Operations experience within a relevant Pharma environment (preferably within a sterile manufacturing environment) you'll bring valuable insights to the team.
Other Qualifications considered beneficial: Professional Engineer Membership (PEM)Six Sigma CertificationProject Management Professional (PMP)Certified Process Engineer (CPE)In addition to the qualifications, consider the following personal attributes:
Flexibility: As part of an agile and growing organization, adaptability to new acquisitions and market demands is crucial.Technical Creativity and Innovation: Your ability to think creatively and innovate, both independently and collaboratively, will contribute to the team's success.Problem-Solving Skills: Recognizing areas for improvement and proactively proposing change programs demonstrates your problem-solving capabilities.International travel of up to about 1-2 weeks may be periodically required.THRIVE What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization.Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsFlexible working from home and remote options available for specific roles within Ireland.APPLY NOW In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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