Bioprocess Technician

Career Category

Manufacturing

Job Description

Bioprocess Technician

Amgen Dun Laoghaire

Live

What you will do

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

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

T he Amgen Manufacturing Site   is   a fast-paced and evolving environment ,   focused on continuous improvement of work processes and practices .   Flexibility is key.   Y ou 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 troubleshootin g, including i nitiation and documentation   of investigations.

P erformance 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 .

S ampling,   testing   and inspections as   required .

Win

What we expect of you

The   successful candidate for this role will bring the following education,   skills   and experience

P ass Leaving Certificate standard or equivalent   -   required

A third level qualification in a relevant subject area   - preferred

Minimum 12 months e xperience 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   with in 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 r esults- focused with   excellent   organizational skills.

Team player with a demonstrated a bility 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

Thrive

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   r etirement and   s avings   p lan with generous company contributions, group medical, life and disability insurance .   D iscretionary 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