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Bachem

Develops and manufactures peptides and oligonucleotides

QA Engineering Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBubendorf, SwitzerlandNo salary listed

About the Job

Requirements

  • A Master's degree in engineering, chemistry, process engineering, pharmacy, or a comparable field, or several years of proven experience in the relevant field.
  • Several years of professional experience in a cGMP-regulated environment.
  • Several years of thorough experience in Quality Assurance.
  • Strong knowledge of Commissioning & Qualification.
  • Strong GMP knowledge, particularly Swiss, EU, and US GMP rules.
  • Very good spoken and written German is required, with solid English proficiency at C1 level.
  • Specific professional experience and thorough knowledge in cleaning validation and/or Computer System Validation.
  • Confidence working with process and document management software such as SAP, MasterControl, or comparable quality management systems.
  • Experienced experts are sought.

Responsibilities

  • Maintain the GMP status of existing facilities over their lifecycle and control requalification and maintenance activities, including change control and deviation procedures.
  • Participate in project-specific qualification and validation activities.
  • Prepare, review, and approve overarching qualification and validation documents.
  • Prepare, review, and approve other GMP-relevant documentation, such as standard operating procedures and logbooks.
  • Support the preparation, conduct, and follow-up of authority inspections and internal customer audits.
  • Analyze existing processes, identify opportunities for optimization, and support implementation of improvements.

About the Company

Bachem

Develops and manufactures peptides and oligonucleotides

Bachem provides development and manufacturing of peptides and oligonucleotides for research, clinical development, and commercial products. Its offerings include custom synthesis and scale-up production, analytical testing, and related services across the drug development spectrum. Customers work with Bachem by specifying desired sequences and specifications, after which Bachem designs, synthesizes, and quality-controls the peptides or oligonucleotides and delivers them in appropriate scales and formats. The company differentiates itself through more than five decades of experience, a global footprint with sites in Europe, the US, and Asia, and an integrated set of services spanning discovery support to commercial manufacturing. Its goal is to help pharmaceutical and biotechnology companies advance peptide- and oligonucleotide-based therapies by providing reliable, scalable, and well-supported manufacturing and development capabilities.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bubendorf, Switzerland
Founded
1971

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