Process/Project Engineer – Pharma Engineering
vor 8 Stunden
Job Summary
We are seeking a proactive and technically skilled
Process/Project Engineer
to support the development, execution, and maintenance of chemical active ingredient manufacturing facilities. The role involves engineering planning, trade coordination, and GMP-compliant project support within self-organized, interdisciplinary teams. The ideal candidate is independent, solution-oriented, and capable of delivering high-quality technical and regulatory outputs.
Key Responsibilities
1. Engineering & Technical Planning
- Independently edit and maintain
P&ID flow diagrams (COMOS)
and ensure data consistency. - Prepare
technical specifications, data sheets, and technical drawings
as planning documents for execution. - Conduct technical testing and approval of
isometrics and production documents
from pipeline builders.
2. Trade Coordination & Construction Management
- Coordinate and control multiple trades (pipeline construction, EI&C, automation, construction) during planning, execution, and commissioning phases.
- Provide
on-site support
to ensure assembly quality and compliance with safety regulations. - Manage resources to ensure efficient execution of small projects.
3. GMP Compliance, Qualification & Change Management
- Define and implement all necessary
change control measures
(organizational, technical, documentary) to ensure compliant change implementation. - Prepare
IQ/OQ verification documentation
(test plans, protocols) and support acceptance activities. - Compile complete
"as-built" documentation
and ensure proper handover to the operator.
Must-Have Qualifications
- Degree in
Process Engineering, Chemical Engineering, Pharmaceutical Technology
, or equivalent higher vocational education (Dipl. Techniker/-in HF) with substantial professional experience. - 5+ years of experience
in the
GMP environment
, with thorough understanding of pharmaceutical production regulations. - Proficiency in
PC applications
; experience with Roche systems (SAP, myBuy, ELIVS/COMOS) is highly advantageous. - Excellent
written and spoken German
, essential for documentation and internal communication. - Independent, proactive, and capable of prioritizing tasks effectively.
- Strong
team collaboration
, communication skills, and commitment to cross-functional success. - High accuracy in technical writing and documentation.
Nice-to-Have
- Previous experience in a
pharmaceutical engineering project environment
. - Familiarity with additional software or project management tools.
-
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