Plant Engineer

Vor 5 Tagen

Basel, Basel-Stadt, Schweiz agap2 Switzerland Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

agap2
is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant
, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what's behind closed doors of the biggest projects of our client's portfolio.

Plant Engineer – Aseptic Filling

Overview

We are seeking an experienced
Plant Engineer
to support
Performance Qualification (PQ)
activities for
aseptic filling lines
in sterile
pharmaceutical manufacturing
. The successful candidate will ensure that filling equipment and associated systems meet performance, quality, and regulatory expectations, contributing to the qualification of robust aseptic production processes.

Key Responsibilities

  • Plan, coordinate, and execute
    Performance Qualification (PQ)
    activities for
    liquid and vial filling lines
    and related systems (isolators, conveyors, cappers, etc.).
  • Define PQ strategy, acceptance criteria, and test plans in alignment with project validation master plans and GMP requirements.
  • Perform PQ testing to verify equipment functionality, process stability, and reproducibility under simulated production conditions.
  • Collaborate closely with
    engineering, quality assurance, validation, and production
    teams to ensure timely and compliant PQ execution.
  • Review and approve
    PQ protocols, deviations, and summary reports
    .
  • Support troubleshooting and ensure timely resolution of qualification-related issues.
  • Ensure all PQ activities comply with
    GMP, FDA, EMA, and EU GMP Annex 1
    requirements.
  • Contribute to
    process validation readiness
    , ensuring equipment qualification supports
    aseptic process integrity
    and upcoming
    media fill
    execution.

Qualifications

  • Bachelor's or Master's degree in
    Engineering, Biotechnology, Pharmacy, or related field
    .
  • Minimum
    3–5 years of experience
    in
    equipment qualification or process validation
    within
    pharmaceutical aseptic manufacturing
    .
  • Proven expertise in
    Performance Qualification (PQ)
    of
    filling equipment
    (liquid and vial filling).
  • Strong understanding of
    aseptic processing principles
    , cleanroom operation, and contamination control.
  • Experience with
    media fills (aseptic process simulation)
    and
    process validation
    is a significant advantage.
  • Familiarity with
    Annex 1, GAMP 5, ASTM E2500
    , and related validation standards.
  • Fluent in both German and English (written and spoken)
    — essential for effective communication and documentation.
  • Excellent technical writing, analytical, and interpersonal skills.

Preferred Skills

  • Experience with
    automated aseptic filling technologies
    and
    isolator-based systems
    .
  • Understanding of
    critical process parameters (CPPs)
    and their linkage to equipment performance and process control.
  • Prior participation in
    tech transfer, facility start-up, or qualification projects
    .

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