Find Sr. manufacturing engineer process quality, hardware engineering manufacturing Jobs in Dublin, D

Process Development Manager
Amgen —Dún Laoghaire, County Dublin
- €78,183–€105,777 a year
- Doctoral degree
- Engineering
- Master's degree
10d
Professional Engineer
ESB —Dublin, County Dublin
- €49,000–€58,000 a year
- Full-time
- AutoCAD
- Project management
- No degree
2d
Senior Engineer
Amgen —Dún Laoghaire, County Dublin
- €70,408.90–€95,259.10 a year
- Remote
- Doctoral degree
- Engineering
- Master's degree
19h
Senior Electrical Specialist, Onshore Renewables
ESB —Dublin, County Dublin
- €71,000–€84,000 a year
- Full-time
- Continuous improvement
- Conflict management
- Mentoring
2d
Associate Director, Data Capability Lead
AstraZeneca —Dublin, County Dublin
- Computer Science
- Master's degree
- AWS
1h
Senior Mechanical Engineer
Mercury Engineering —Dublin, County Dublin
- Construction experience
Director of Sales Engineering
Tate Europe —Dublin, County Dublin
- Full-time
- Sales
- Engineering
- Master's degree
Quick apply
E&I (Electrical & Instrumentation) Department Manager
DPS Group —Dublin, County Dublin
- Full-time
- Engineering
- In-person
- Manufacturing
Senior Electrical Engineer
Mercury Engineering —Dublin, County Dublin
- Construction experience
Senior Engineer - Civils
Sisk —Blanchardstown, County Dublin
- Full-time
- Engineering
- Microsoft Office
- Bachelor's degree
- Annual leave
Senior Design Manager
Sisk —Dublin, County Dublin
- Full-time
- Research
- No degree
- Contracts
- Annual leave
CSA Engineer
Mercury Engineering —Dublin, County Dublin
- Construction experience
Principal Mechanical Engineer
Tetra Tech —Dublin, County Dublin
- Part-time
- Manufacturing
- Leadership
- Communication skills
Civil Engineer - AF Electronics
Jacobs —Dublin, County Dublin
- Hybrid work
- CAD
- Bachelor's degree
- No degree
Senior Electrical Engineer - Aviation
Sisk —Dublin, County Dublin
- Full-time
- Analysis skills
- Plumbing
- Mentoring
- Annual leave
Electrical Sales Engineer
Tate Europe —DUBLIN 10, County Dublin
- Full-time
- Microsoft Word
- AutoCAD
- Microsoft Excel
Quick apply
Senior Estimator - Life Sciences
Jacobs —Dublin, County Dublin
- Hybrid work
- Microsoft Excel
- Master's degree
- Bachelor's degree
Mechanical Discipline Lead (Semiconductor)
DPS Group —Leixlip, County Kildare
- Full-time
- System design
- Bachelor's degree
- Mechanical knowledge
13d
Mechanical Designer (Semiconductor)
DPS Group —Leixlip, County Kildare
- Full-time
- AutoCAD
- Microsoft Excel
- Engineering
13d
Electrical Designer(Semiconductor)
DPS Group —Leixlip, County Kildare
- Full-time
- AutoCAD
- Communication skills
13d

I want to receive the latest job alerts for sr. manufacturing engineer process quality, hardware engineering manufacturing in dublin, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

sr. manufacturing engineer process quality, hardware engineering manufacturing jobs near dublin, d

Engineer jobs in Dublin, County Dublin

Senior Design Manager jobs in Dublin, County Dublin

Civil Engineer jobs in Dublin, County Dublin

Senior Electrical Engineer jobs in Dublin, County Dublin

Sales Director jobs in Dublin, County Dublin

Department Manager jobs in Dublin, County Dublin

Senior Mechanical Engineer jobs in Dublin, County Dublin

Mechanical Engineer jobs in Dublin, County Dublin

Senior Estimator jobs in Dublin, County Dublin

Customer Service Representative jobs in Dublin, County Dublin

Senior Administrator jobs in Dublin, County Dublin

Senior Engineer jobs in Cork, County Cork

Senior Engineer jobs in Waterford, County Waterford

Software Engineer jobs in Limerick, County Limerick

Software Engineer jobs in Waterford, County Waterford

Senior Engineer jobs in County Mayo

Senior Engineer jobs in Dublin, County Dublin

Engineer jobs in Clonmel, County Tipperary

Engineer jobs in County Waterford

Ai Engineer jobs in Dublin, County Dublin

Process Development Manager

Amgen -
Dún Laoghaire, County Dublin

Apply Now

Job details

€78,183–€105,777 a year
10 days ago

Qualifications

Doctoral degree
Engineering
Master's degree
Project management
Bachelor's degree
Quality systems
Manufacturing
Leadership
Communication skills

Full job description

Ireland - Dun Laoghaire

JOB ID: R-252992 LOCATION: Ireland - Dun Laoghaire WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Aug. 17, 2026 CATEGORY: Process Development SALARY RANGE: 78,183.00 EUR - 105,777.00 EUR

Overview:

The Process Development Manager– will report to the Sr. Manager Process Development for New Product Introduction (NPI) Technical Delivery and will be responsible for technical delivery of NPIs and life cycle management (LCM) products to ADL. The successful candidate will have at least five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading tech transfers and process validation activities as well as managing teams.

Job Scope:

This role will require the candidate to manage a team of tech transfer engineers/scientists as well as lead tech transfers of NPIs and LCMs to ADL. The candidate will provide technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global Process Development (PD) organization. The input provided will also include support of process performance and implementation of process improvement strategies and will include the following:

Leads new product introductions and lifecycle changes into the vial and syringe plants from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
Manage a team of tech transfer engineers/scientists supporting other vial and syringe transfers to Dun Laoghaire.
Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.
Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
Provide 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.
Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
Identifies and implements operational opportunities for current and new sterile operations.
Troubleshoots issues with drug product processing technologies and equipment.
Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to senior management. Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert.
Development of validation plans, process performance qualifications (PPQs) for vial and syringe filling.
Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures.
Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
Input to site validation guidance documents.
Collate and report on relevant shipping and filter validation.
Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
Contribute to product quality assessments and process flow documents.
Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.
Lead or assist in deviation and exception resolution and root cause analysis.
Participate as required in project activities and be developing own project management techniques.

Basic Qualifications:

A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience
Knowledge of cGMPs and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications skills

Preferred Qualifications:

PhD or Masters in Science or Engineering
5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding 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 skill is essential for this role.

Amgen is an equal opportunities employer.

Apply Now

Refine Your Search

sr. manufacturing engineer process quality, hardware engineering manufacturing jobs in dublin, d

Process Development Manager

Professional Engineer

Senior Engineer

Senior Electrical Specialist, Onshore Renewables

Associate Director, Data Capability Lead

Senior Mechanical Engineer

Director of Sales Engineering

E&I (Electrical & Instrumentation) Department Manager

Senior Electrical Engineer

Senior Engineer - Civils

Senior Design Manager

CSA Engineer

Principal Mechanical Engineer

Civil Engineer - AF Electronics

Senior Electrical Engineer - Aviation

Electrical Sales Engineer

Senior Estimator - Life Sciences

Mechanical Discipline Lead (Semiconductor)

Mechanical Designer (Semiconductor)

Electrical Designer(Semiconductor)

I want to receive the latest job alerts for sr. manufacturing engineer process quality, hardware engineering manufacturing in dublin, d

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected