Manufacturing Operations Specialist

Biopharma Careers; Waterford; On-site; EUR 42,000 - 55,000; Full time

Benefits offered by this job

Onsite gym

Medical centre

Flexible working

Job summary

Sanofi Waterford is seeking a Manufacturing Specialist to join our on-site operations. You will apply knowledge of QMS, compliance and cGMP to manage investigations and improvement initiatives within manufacturing.

This is a fixed-term, full-time position for 23 months in Waterford. The role requires experience in a cGMP environment; training and collaboration with cross-functional teams, and participation in audits and CAPA processes.

Qualifications

• Experience in a cGMP manufacturing environment is essential.
• Previous steriles experience is desirable.

Responsibilities

• Works on site ensuring products are manufactured, stored and packaged per cGMP.
• Supports investigations to determine root cause and implement CAPA.
• Develops and maintains training materials on process operations and compliance.
• Performs audits and maintains the quality system on site.
• Reviews procedures and batch documentation with cross functional teams.

Skills

cGMP knowledge

Problem solving

Analytical skills

Technical writing

Training delivery

Quality systems

Tools

MES/SCADA

SAP

Job description

Location: Waterford

Job type: Fixed term - 23 months, Full time

This position is a on days.

About Waterford

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 work together at a state-of-the-art biopharmaceutical and medical device campus. Recognised through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical centre that underpin a strong commitment to health and wellbeing.

The Role:

The Manufacturing Specialist uses knowledge of QMS, compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.

Core Responsibilities:

• Working as part of the Manufacturing team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
• Practices and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines.
• Supports cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Preventive Action.
• Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
• Conducts documents revisions and/or document management including batch production records, manufacturing procedures, and cross functional procedures.
• Works with manufacturing Team Leaders and managers to develop and maintain training materials and curricula on process operations, theory and compliance.
• Performs training with staff on the floor as needed.
• Support the development of GMP training packages and delivery of training
• Participate in the preparation and review of procedures and batch documentation
• Perform audits of all areas to agreed schedule
• Ensure the quality system at Sanofi is effectively implemented and maintained
• Ensure practices meet cGMP requirements
• Actively review, identify and initiate CI projects
• Support Projects for Manufacturing as required

About You

To excel in this role you will need to have:

Essential requirements:

• Previous steriles experience is desirable
• Experience of working in a cGMP manufacturing environment is essential

It would be advantageous to have (not essential):

• Competent in the operation, cleaning, maintenance of all manufacturing equipment
• MES/SCADA and SAP experience
• Good problem solving and analytical skills
• Demonstrated good understanding of mechanical operations
• Technical writing skills
• Good knowledge of cGMP
• Excellent interpersonal skills
• Understands site KPI’s

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watchour ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watchour ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€41600,00 - €55467 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.