CrawlJobs Logo

Sr. Project Equipment Engineer / System Owner

amgen.com Logo

Amgen

Location Icon

Location:
Ireland , Dun Laoghaire

Category Icon
Category:
-

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Amgen Dun Laoghaire (ADL) is looking for a Sr. Project / Equipment Engineer to join our facilities & engineering team to support the continued expansion of the plant and production capability on site. The Sr. Project / Equipment Engineer will report to the Associate Director for Facilities & Engineering and is responsible for portfolio ownership, scoping and executing technical projects within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and Inspection areas. This includes new product introductions, qualification of new equipment and implementation of associated reliability and maintenance programs.

Job Responsibility:

  • Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion
  • Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
  • Coordination of engineering readiness scoping and readiness for new product introductions
  • Project management and execution of assigned projects including project prioritization, resources management, status management and external communication
  • Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and commercial operational readiness
  • Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment
  • Ability to translate strategic/emerging technology solutions into pragmatic executable plans
  • Development and management of change controls
  • Participate as a member of multidisciplinary site and multisite teams
  • Development of detailed specifications, engineering documents, protocols and standard operating procedures
  • Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations
  • Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits
  • Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures
  • Support a safe working environment by complying with environmental health/safety practice, rules and regulations
  • Travel may be required to support execution of projects

Requirements:

  • Bachelor’s degree in engineering (Mechanical, Electrical or Chemical) or Relevant Experience
  • Typically, 5+ years’ engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes
  • Technology transfer experience preferred
  • Proven project management experience
  • Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
  • Demonstrated experience in a GDP Compliant environment
  • Experience in MS Office, MS Project, Change Control & Document Management Systems
  • Proven ability working cross functionally, delivering technical solutions and implementing improvements
  • Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results
  • Technical report writing and communication/presentation skills
  • Data driven decision maker
  • Ability to work to tight deadlines in a fast-moving environment

Nice to have:

  • Technology transfer experience preferred
  • Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
What we offer:
  • Competitive salary structure
  • Generous Total Rewards Plan for staff and eligible dependents
  • Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance
  • Discretionary annual bonus program
  • Exceptional learning, development and career advancement opportunities

Additional Information:

Job Posted:
January 18, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Amgen - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sr. Project Equipment Engineer / System Owner

New

Sr. Engineer - Reliability System Owner (Drug Substance Ops)

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...
Location
Location
United States of America , Juncos
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree in Engineering
  • Or Master's degree in Engineering and 2 years of Engineering and/or Mfg Support experience
  • Or Bachelor's degree in Engineering and 4 years of Engineering and/or Mfg Support experience
  • Experience in equipment reliability, lifecycle management, and performance optimization
  • Knowledge of reliability engineering tools and techniques, including FMEA (Failure Modes and Effects Analysis) and predictive maintenance strategies
  • Proficiency in structured problem‑solving methodologies, such as DMAIC, and root cause analysis tools including Fishbone diagrams and related techniques
  • Proficiency in statistical analysis, Design of Experiments (DOE), and data‑driven decision‑making
  • Knowledge of Drug Substance Downstream operations and equipment, including chromatography columns, buffer preparation systems, analytical systems, and bioreactors (with strong emphasis on downstream processes)
  • Demonstrated ability to lead and collaborate with multi‑functional teams to resolve system‑level technical challenges
  • Skilled in translating complex technical data into clear, actionable insights for diverse stakeholders
Job Responsibility
Job Responsibility
  • Own the reliability, performance, and lifecycle of critical systems and equipment
  • Act as System Owner for assigned equipment and systems, maintaining full technical accountability for performance, reliability, and validated state
  • Investigate unexpected system and equipment failures, performing root cause analysis and leading the development and execution of corrective and preventive actions
  • Define, own, and continuously optimize equipment reliability strategies, including maintenance strategy, risk mitigation, and lifecycle management
  • Develop, implement, and improve Preventive Maintenance (PM) strategies and job plans, optimizing maintenance frequencies based on data, failure modes, and reliability analysis
  • Lead efforts to optimize maintenance intervals through data driven optimization while ensuring equipment reliability, compliance, and validation integrity
  • Ensure availability and management of spare parts, including identification of critical spares, inventory monitoring (stock / non‑stock), and coordination with technical and maintenance teams
  • Maintain equipment in a validated state, ensuring data integrity, system compliance, and alignment with cGMP and regulatory expectations
  • Serve as technical owner for equipment improvement and upgrade projects, including reliability enhancements and performance optimization initiatives
  • Support New Equipment Introduction (NEI/NPI) activities, ensuring equipment meets user requirements, specifications, validation needs, and operational readiness
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and an annual site shutdown
  • Flexible work models, including remote work arrangements, where possible
  • Fulltime
Read More
Arrow Right

Sr. Associate Manufacturing Production Process Owner

In this vital role you will partner with cross-functional teams—including Engine...
Location
Location
United States , Thousand Oaks
Salary
Salary:
92002.00 - 108605.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school/GED + 4 years Manufacturing support experience
  • Associate’s + 2 years Manufacturing support experience
  • Bachelor’s + 6 months Manufacturing support experience
  • Master's
  • Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
  • Experience in aseptic Drug Product or biologics manufacturing
  • Knowledge of process validation, deviation management, and change control
  • Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
  • Excellent written and verbal communication skills and ability to collaborate across functions
Job Responsibility
Job Responsibility
  • Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
  • Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards
  • Maintain documentation to accurately reflect operational practices and regulatory requirements
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements
  • Support timely investigation and resolution of manufacturing deviations
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Sr. Engineer - System Owner (Inspection & Packaging)

Amgen Dun Laoghaire (ADL) is looking for a Senior Engineer to join our Inspectio...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in engineering (Mechanical, Electrical or Mechatronic preferred)
  • Senior level experience of providing technical solutions in the medical device, pharmaceutical inspection or medical packaging sectors
  • Demonstrated solid leadership, with the ability to build teams and operate across functional boundaries, both internal and external
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices
  • Demonstrated experience of vendor management and contract negotiations with focus on equipment suppliers, SLA’s and continuous supplier performance
  • Significant experience large project related activities including GMP qualification experience
Job Responsibility
Job Responsibility
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
  • Ownership of equipment/systems in a GMP regulated manufacturing setting
  • Monitoring of day-to-day performance of their assigned system
  • Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends
  • Proactively identify opportunities for continuous improvement in equipment & processes as well as preventative maintenance support to technicians for regular activities
  • Anticipate issues and plan effective preventative solutions in a timely matter and plan works around a busy manufacturing schedule and defined available resources
  • Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
  • Ownership of all GMP documentation and their accuracy throughout the lifetime of the equipment (e.g. Risk assessments, Functional Design, User Requirement specifications etc.)
  • Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems and follow up to ensure learnings are actioned
  • Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high system performance
  • Fulltime
Read More
Arrow Right

Rig Systems Engineer III

The Rig Systems Engineer for integrated facilities is responsible for leading pr...
Location
Location
United States , Houston
Salary
Salary:
Not provided
airswift.com Logo
Airswift Sweden
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in engineering or a related field
  • Minimum of 5-7 years of experience in project management within the oil and gas industry, specifically in offshore drilling and rig operations
  • Experience in managing rig stacking plans and ensuring safe and compliant demobilization activities
  • Proven track record of managing large-scale projects and leading multi-disciplinary teams
  • Strong understanding of drilling contractor relationships and contractual obligations
  • Experience with budget development, cost control, and value improvement practices
  • Proficient in project management standards, reporting, and process governance
  • Ability to provide innovative engineering solutions to enhance rig efficiency and safety
  • Experience in technology integration and driving the adoption of new technologies
  • Strong skills in maintenance and improvement processes, including risk assessments and audits
Job Responsibility
Job Responsibility
  • Plan and execute offshore projects in coordination with the Sr. Rig Engineer, Well Superintendent, Project Engineers, Planners, and stakeholders across Wells and Production
  • Interpret and manage drilling contractor relationships and contractual obligations
  • Lead two agile contractor teams to deliver asset management and maintain project objectives
  • Oversee development and update of 5-year maintenance plan and project strategy on an annual basis, including scope prioritization, phasing, and financial forecasting
  • Validate invoices and value of work done by the rig contractor
  • Develop the annual capital budgets, track earned value, forecast-to-complete, and implement value improvement practices
  • Establish and maintain project management standards and reporting consistency across teams, including project performance and KPI’s
  • Facilitate day-to-day needs of Well Superintendents and coordinate with functional groups in Wells and Production
  • Provide innovative engineering and operational solutions to enhance rig efficiency and safety
  • Drive adoption of new technologies, capture lessons learned and integrate improvements into standards and design
Read More
Arrow Right

Sr Quality Engineer

As directed by the Quality Engineering Leader, the Quality Engineer II or Sr Qua...
Location
Location
United States , San Diego
Salary
Salary:
38.00 - 41.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 3-5 years of experience in Medical Device, Biotech or Pharma Industry
  • Must have Validation, Nonconformance and CAPA experience
  • BS Biological Sciences, Chemistry, Bio-tech engineering, Bio-engineering or related field
  • Strong verbal and written communication skills
  • ability to write technical documents
  • Knowledge of quality system methodologies
  • Statistical Analysis basic knowledge e.g Minitab or Excel
  • Strong knowledge of Design Control, Process Validation and Supplier Management
  • Strong understanding and knowledge on ISO 9001, ISO 14971 and/or ISO 13485 (Design Control, Supplier Management and Risk Management)
  • Hands on experience using Six Sigma methodology
Job Responsibility
Job Responsibility
  • Experience with addressing any internal quality issues and help team to resolve it in timely manner with production, quality, and regulatory compliance need
  • Part of MRB team to help team to create or drive quality notification to release the material
  • Experience performing equipment and process validation studies such as writing and/or reviewing protocol, report, data analysis and deviations for new, existing and site relocation activities
  • Have a working knowledge of medical device or biological equipment maintenance from Quality standpoint such as Preventive Maintenance, Calibration and Out Of Tolerance activity support to the site and equipment owners
  • Experience performing supplier qualification including Audits and surveys with quality/purchasing/planning team to complete the supplier risk classification and supplier approval list
  • Support Supplier Corrective Action and Investigation activity to represent the Customer side
  • Experience on CAPA(Corrective Action and Preventive Action) for internal and external complaints or Non conformance or continuous improvement activities
  • Fulltime
Read More
Arrow Right
New

Sales Associate

Location
Location
United States , San Diego
Salary
Salary:
18.00 USD / Hour
skinlaundry.com Logo
Skin Laundry
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 1–2 years of retail, hospitality, or service experience required
  • Intermediate knowledge of retail operations, POS systems, and cash handling
  • Familiarity with Zenoti or similar scheduling and sales software
  • Strong product knowledge and passion for skincare and client education
  • Advanced interpersonal skills with the ability to coach peers and foster teamwork
  • Strong communication and problem-solving abilities
  • Reliable, proactive, and accountable in daily execution
  • Must be at least 18 years of age
  • Must be available and able to work weekends (sat AND sun) regularly
  • Must have availability to work a minimum of 4 days per week
Job Responsibility
Job Responsibility
  • Lead by example in achieving daily sales and conversion goals
  • Deliver exceptional client service by educating clients on products, memberships, and treatments
  • Support clinic-wide retention and loyalty programs through relationship building and consistent follow-up
  • Reinforce Skin Laundry's service standards and brand values during every client interaction
  • Support opening and closing procedures, including register reconciliation, invoice closeout, and clinic readiness
  • Maintain accurate inventory levels by assisting with restocking, receiving shipments, and product counts
  • Ensure cleanliness, organization, and merchandising standards are consistently met
  • Execute operational checklists and compliance tasks as directed by the ACM or CM
  • Provide on-the-floor coaching and real-time feedback to Sales Associates
  • Support onboarding and training of new team members under ACM/CM guidance
What we offer
What we offer
  • Skin Laundry Employee Treatment & Product Discount Program
  • 5 ways we give back to YOU
  • We are committed to your growth
  • Work/Life Balance
  • You will be led, not managed
  • Speak Up Culture
  • We don't hire jerks
  • Parttime
Read More
Arrow Right
New

Assistant Accounting Manager

Job opening - Assistant Accounting Manager in Bukit Mertajam | Randstad
Location
Location
Malaysia , Bukit Mertajam
Salary
Salary:
6000.00 - 9500.00 MYR / Month
https://www.randstad.com Logo
Randstad
Expiration Date
July 02, 2026
Flip Icon
Requirements
Requirements
  • Minimum LCCI diploma, Bachelor's Degree in Accounting, ACCA, CIMA, or equivalent professional qualification
  • Minimum 3 years of hands-on working experience in the manufacturing sector handling full sets of accounts
  • Familiarity with the SAP system or other major ERP systems is required
  • Strong conceptual, analytical, and problem-solving skills
  • ability to work independently and collaboratively to meet tight deadlines
  • excellent written and verbal communication and presentation skills
Job Responsibility
Job Responsibility
  • Oversee all day-to-day accounting functions and manage the full monthly closing process, ensuring organizational financial stability and accuracy
  • Monitor and assist in cash flow management and planning for the corporate headquarters, implementing effective credit management and collection strategies to improve working capital
  • Collaborate effectively with cross-functional departments to resolve accounting issues and ensure a smooth, timely monthly closing activity
  • Lead the forecasting and budgeting cycles, integrating finance operations with business strategy to provide forward-looking data
  • Conduct in-depth financial reporting and variance analysis, working closely with executive teams to share insights, optimize operational cost efficiency, and reduce expenses across the business
  • Analyze and prepare financial statements for consolidation purposes, including necessary schedules for tax compliance
  • Present detailed financial reports and highlight potential risk areas to senior management, supporting data-driven strategic decisions
  • Act as the primary liaison and engagement point for external professional parties, including auditors, tax agents, bankers, lawyers, and the Company Secretary
  • Ensure timely and substantive responses to internal and external audit recommendations, taking ownership of the development and implementation of corrective action plans
  • Responsible for the preparation of all supporting audit schedules and documentation required for external reviews, ensuring full statutory compliance
  • Fulltime
Read More
Arrow Right
New

Accountant

Location
Location
Malaysia , Sungai Buloh
Salary
Salary:
6000.00 - 10000.00 MYR / Month
https://www.randstad.com Logo
Randstad
Expiration Date
July 05, 2026
Flip Icon
Requirements
Requirements
  • Must be a member of MIA/ MICPA/ACCA/CIMA
  • Degree in Accounting, Finance, or a related field with professional qualification
  • At least 3 years of experience in audit or tax
  • Strong proficiency in ERP Financial systems and computer literacy
  • Deep knowledge of Malaysia Financial Reporting Standards (MFRS)
  • Advanced skills in auditing, accounting, and costing
Job Responsibility
Job Responsibility
  • Execute the end-to-end financial reporting process, including preparing and reviewing all journal entries, general ledger postings, and account reconciliations
  • Prepare financial statements in full compliance with the latest Malaysian Financial Reporting Standards (MFRSs)
  • Review management accounts and prepare reports for the holding company
  • Conduct detailed P&L and balance sheet commentary, including gross profit analysis, financial ratio analysis, and profitability reviews
  • Perform detailed cash flow forecasting to manage the Company's liquidity
  • Act as a point of contact with bankers regarding statutory filings and banking compliance
  • Review and verify the propriety of credit notes (CNs) and debit notes (DNs) for both accounts payable and receivable
  • Manage yearly income tax filings, including IRB returns and CP204 notifications
  • Handle tax-related matters, including SST (Sales and Service Tax), withholding tax, and other indirect tax issues
  • Manage and maintain Transfer Pricing documentation, specifically the Master File and Local File
Read More
Arrow Right