Engineering Technical Lead – Biopharma Project

Dusseldorf, Germany | Posted on 17/03/2026

Industry Pharma/Biotech/Clinical Research
Work Experience 5+ years
Country Germany
Postal Code 40210

About Us

Pharmalliance offers expert support to pharmaceutical companies to maintain and increase quality compliance levels.

We specialize in cGMP Compliance, Remediation and Contamination Control and have a suite of services to help you stay compliant no matter what your stage of development.

Job Description

This opportunity is to join a pharmaceutical manufacturing project in Germany as an Engineering Technical Lead, supporting process scale-up and equipment implementation activities.

The Engineering Technical Lead will provide client-side technical leadership for a pharmaceutical manufacturing project involving process scale-up and will support equipment implementation (led by individual equipment project managers). The role will focus on engineering oversight, technical execution, risk assessment, and high-level commissioning and qualification (CQV) planning for fermentation, process, CIP, and SIP operations for new equipment integration.

The position supports engineering teams responsible for process equipment, utilities, and facility systems and ensures activities align with GMP and regulatory expectations. The role includes responsibility for engineering batches, including the preparation of required documentation such as protocols and reports.

Key Responsibilities

Support scale-up activities for the complete process
Act as the primary technical reference for engineering decisions and technical issue resolution
Support identification and mitigation of technical and operational risks
Provide oversight for engineering, quality, compliance, and support CQV workflows
Act as the first point of contact for all technical and process-related questions
Define the scope of engineering batch protocols and prepare associated documentation (protocols and reports)
Coordinate day-to-day activities related to engineering batches
Ensure engineering solutions align with scale-up goals, GMP expectations, and industry best practice
Coordinate with engineering, quality, CQV, and operations teams to support execution
Ensure all documentation is prepared in compliance with corporate quality standards

Qualifications & Experience

Degree in Engineering, Science, or a related discipline
8+ years of experience across the full cGMP project lifecycle within the pharmaceutical or biotech industry
Good understanding of biotechnological processes (yeast preferred)
Strong knowledge of GMP, EU Annex 15, and ISPE guidelines
Experience with utilities, process equipment, and automation systems
Excellent documentation and technical writing skills
Ability to work independently and manage multiple priorities
Fluency in English (German is a plus)
Strong stakeholder management and communication skills
Detail-oriented with a focus on quality and compliance
Problem-solving mindset with the ability to resolve technical and compliance issues
Proactive and hands-on approach

Application Process

Interested candidates are invited to submit their CV and a cover letter outlining relevant experience in pharmaceutical project execution and involvement in process scale-up and equipment integration within regulated environments.

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Pharmalliance Consulting Ltd.