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.
Process Engineer – Aseptic Filling
Overview
We are seeking an experienced
Process 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
.