Senior Production Associate USP

WuXi Biologics; Wuppertal; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

WuXi Biologics in Germany is seeking a Senior Production Associate Upstream (m/f/d) to support the Shift Lead in daily biopharmaceutical manufacturing operations, ensuring quality, safety, and performance targets are met.

You will guide manufacturing personnel, coordinate with Quality, Engineering and cross-functional partners, maintain GMP documentation, and participate in audits, CAPAs, and continuous improvement initiatives while upholding cGMP and EHS standards.

Qualifikationen

• Apprenticeship or a comparable qualification in chem/bio fields or a degree in natural sciences/engineering.
• Minimum 3 years in biopharmaceutical manufacturing or related field.
• Experience with GMP documentation, deviation management, CAPA and Change Control is advantageous.

Aufgaben

• Provide technical guidance and support to manufacturing personnel
• Support the planning and execution of manufacturing activities
• Coordinate activities with Quality, Engineering, and other cross-functional partners
• Conduct and support training activities within the production environment
• Prepare and maintain GMP-related documentation
• Support audits, deviation investigations, CAPAs, and change controls
• Participate in continuous improvement initiatives and troubleshooting activities
• Ensure compliance with cGMP, quality, and EHS requirements

Kenntnisse

Upstream manufacturing

Biopharma manufacturing

Process control systems

GMP documentation

CAPA

Change Control

Cell culture

Inoculation

Fermentation

Single-use technologies

Wave & SUB

cGMP

English (B2)

Ausbildung

Apprenticeship or comparable qualification (Chemikant/Pharmakant/CTA/BTA)

Degree in Natural Sciences or Engineering

Tools

ABB

DeltaV

Jobbeschreibung

Senior Production Associate Upstream (m/w/d)

Qualifikation

Senior Production Associate Upstream (m/f/d)

Your Mission

As a Senior Production Associate Upstream, you will support the Shift Lead in managing daily manufacturing operations and act as their technical deputy when required. You will help coordinate production activities, support manufacturing personnel, and play a key role in achieving quality, safety, and operational performance targets.

Your Responsibilities

• Provide technical guidance and support to manufacturing personnel
• Support the planning and execution of manufacturing activities
• Coordinate activities with Quality, Engineering, and other cross-functional partners
• Conduct and support training activities within the production environment
• Prepare and maintain GMP-related documentation
• Support audits, deviation investigations, CAPAs, and change controls
• Participate in continuous improvement initiatives and troubleshooting activities
• Ensure compliance with cGMP, quality, and EHS requirements

What You'll Bring

Qualifications

• Apprenticeship as a Chemikant, Pharmakant, CTA, BTA, or a comparable qualification
• Alternatively, a degree in Natural Sciences, Engineering, or a related field

Experience

• Minimum of 3 years of experience in biopharmaceutical manufacturing
• Strong hands-on experience within an Upstream manufacturing environment
• Experience with process control systems such as ABB or DeltaV
• Experience with GMP documentation, deviation management, CAPA, and Change Control is advantageous

Technical Knowledge

• Experience with cell culture, inoculation, fermentation, single-use technologies (Wave & SUB), centrifugation, and depth filtration
• Sound understanding of cGMP and EHS requirements
• English language skills at B2 level or above are desirable

What Sets You Apart

• Strong communication and interpersonal skills
• Proactive mindset and a high level of ownership
• Structured and solution-oriented approach to work
• Ability to technically guide and support small teams
• Strong organizational and prioritization skills

What We Offer

• A responsible role with opportunities for professional growth
• A modern biopharmaceutical manufacturing environment
• Exciting challenges and opportunities to drive improvements
• Collaboration within a highly motivated cross-functional team
• Continuous learning and development opportunities

Working Conditions

• Flexibility to support different working time models; shift work may be required depending on business needs
• Occasional weekend and public holiday work may be necessary
• Availability for on-call duty based on operational requirements

Bring your expertise, take ownership, and help shape the future of biopharmaceutical manufacturing.