Manufacturing Process Technician

Biopharma Careers; Dublin; On-site; EUR 39,000 - 53,000; Full time

Benefits offered by this job

Total rewards plan

Discretionary annual bonus

Medical, life and disability insurance

Career development opportunities

Job summary

Amgen Dun Laoghaire is seeking a Manufacturing Process Technician – Inspection to join the Operations Organization. You will report to the Shift Manager and be responsible for activities related to the manufacture of sterile parenteral drugs.

The site is fast-paced with a focus on continuous improvement of processes. A shift pattern is required; opportunities for development and a comprehensive benefits package are provided.

Qualifications

• Pass Leaving Certificate standard or equivalent – required.
• A third level qualification in a relevant subject area – preferred.
• Minimum 12 months experience in sterile pharmaceutical manufacturing or 2 years in GMP/regulatory environment.
• Demonstrated knowledge of GMP principles and aseptic practices; aseptic experience preferred.
• Drug product manufacturing experience.
• Experience with equipment used in parenteral manufacturing such as autoclaves, filling lines, and formulation vessels.
• Knowledge of Right First Time (RFT) techniques and lean manufacturing concepts.
• Strong problem-solving and communication skills; team-oriented and results-driven.
• Fluent written and spoken English required.

Responsibilities

• Set up manufacturing equipment and process parts; operate systems like EBR/LIMS.
• Adhere to GMP, safety regulations, and Amgen requirements.
• Troubleshoot problems; initiate and document investigations.
• Conduct self-inspections during Quality & Safety Audits.
• Support audits by Corporate, FDA, IMB and regulators.
• Engage in MAP learning and development program.
• Provide cross-functional training within the team.
• Maintain and review operational documentation and reviews.

Skills

GMP principles

Aseptic knowledge

RFT techniques

Lean manufacturing

Problem-solving

Communication skills

Team player

English fluency

Education

Leaving Certificate

Third level qualification

Tools

Autoclaves

Filling lines

Formulation vessels

LIMS/EBR systems

Job description

Manufacturing Process Technician – Inspection

Amgen Dun Laoghaire

Live

What you will do

Let’s do this. Let’s change the world. As part of Amgen’s Operations Organization, our Manufacturing Function continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.

As a Manufacturing Process Technician, you will report into the Shift Manager. In this role, you will have responsibility for activities relating to the manufacture of sterile parenteral drugs.

The Amgen Manufacturing Site is a fast-paced and evolving environment, focused on continuous improvement of work processes and practices. Flexibility is key. You may be asked to carry out additional work functions, associated with the role, as designated by management, at times.

The successful candidate will be required to work a shift pattern.

Key Responsibilities

• Set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, etc. and cleaning and sanitization of production areas.
• Perform duties with due care and in accordance with Good Manufacturing Practices (GMP), Safety Regulations and Amgen requirements.
• Problem solving and troubleshooting, including initiation and documentation of investigations.
• Performance of self-inspection during Quality & Safety Audits.
• Support Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
• Participate in the learning and development program via the Maximizing Amgen Performance (MAP) process.
• Support cross functional training across team members.
• Ownership for the use, review, revision and upgrade of operational documentation and peer review of operations.
• Play a key role in the development of manufacturing systems
• Proactively identify operational improvement and continuous improvement opportunities and / or process related issues including escalation & follow up for effective resolution and implementation.
• Champion safe working practices and safety initiatives.
• Sampling, testing and inspections as required.

What we expect of you

• Pass Leaving Certificate standard or equivalent - required
• A third level qualification in a relevant subject area - preferred
• Minimum 12 months experience of operations within a sterile pharmaceutical manufacturing or similar environment OR Minimum 2 years of experience in a GMP and / or equivalent regulated environment.
• Demonstrated knowledge of GMP principles and aseptic knowledge within GMP areas. Aspectic experience preferred.
• Drug product manufacturing experience.
• Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels.
• Demonstrated understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts.
• Demonstrated mechanical aptitude
• Excellent problem-solving and communication skills
• Experience working in Grade A/B area in Graded Aseptic Areas.
• Proactive and results-focused with excellent organizational skills.
• Team player with a demonstrated ability to work effectively with colleagues and peers in a cross functional environment
• Proven ability to deliver to personal, team and site objectives.
• Fluent written and spoken English required

What you can expect of us

In addition to a competitive salary structure, Amgen offers a 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, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.

Amgen is an equal opportunities employer.

Salary Range

39,477.40 EUR - 53,410.60 EUR