Beschreibung

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Firma: CMET Engineering (Turnover Specialists)

UNTERNEHMENS-ID: 94163329
Stellenausschreibungs-URL: https://de.linkedin.com/jobs/view/quality-and-turnover-electrical-and-instrumentation-engineer-at-cmet-engineering-turnover-specialists-4443919191?position=2&pageNum=3&refId=A6%2Fq7rz1vPBXdaamhxNz6w%3D%3D&trackingId=QsnpnlVO%2FvMGFpILrgfGHQ%3D%3D

Karrierestufe

Berufseinstieg

Beschäftigungsverhältnis

Vollzeit

Tätigkeitsbereich

Ingenieurwesen und IT

Branchen

Baugewerbe
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Job titles: Quality Control (QC) (ELV and I&C)
As a Quality Controller on a pharmaceutical construction site, the candidate plays a critical role in ensuring that all construction activities meet the stringent quality standards required for pharmaceutical environments. Reporting to the Site QA/QC Manager, the Quality Controller is responsible for conducting inspections, documenting compliance, and supporting the implementation of the Project Quality Plan (PQP), Site Quality Plan (SQP) and relevant project specifications.

Key Responsibilities:
Report to the Site QAQC Manager
Perform daily inspections and surveillance of construction activities to ensure compliance with project specifications, industry standards, and regulatory requirements.
Document and report QA/QC findings, including non-conformances, deviations, and corrective actions.
Verify that materials are stored and handled according to manufacturer specifications and project guidelines.
Review installation procedures and ensure adherence to approved drawings and technical details.
Maintain detailed records of inspections, test results, and quality documentation in alignment with the site-specific QA/QC program.
Support the resolution of quality issues by coordinating with contractors and site supervisors.
Assist in verifying compliance with contractual and technical requirements during construction.
Participate in quality audits and contribute to continuous improvement initiatives.

Deliverables
·        Review Contractors’ quality documents, including ITPs, FOK, and test protocols in accordance with the Project Requirements
·        Ensure that all materials, equipment, and installation works comply with applicable codes, clients’ requirements, and project quality procedures
·        Perform independent quality control and verification of installation, testing and commissioning of ELV and I&C systems including but not limited to:
– Building Management Systems (BMS)
– Environmental Monitoring Systems (EMS)
– Access Control, CCTV, Fire Alarm, LAN/IT infrastructure (ELV part)
– PLC/SCADA systems
– Process instrumentation (pressure, temperature, flow, level, conductivity, pH, etc.)
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Cleanroom qualification – related sensors and control loops
·        Review and approve inspection and test plan (ITP), test protocols, test packs, loop checks, calibration certificates, SAT/FAT documentation and as-built drawings.
·        Witness and sign-off functional tests, loop checks, alarm tests, interlock tests and integrated system tests.
·        Ensure full traceability and compliance with EU-GMP, GAMP 5, DIN/EN/IEC standards and client specifications.
·        Identify, document and follow up on QORs, non-conformances (NCR), punch items and deviations until closure.
·        Coordinate with contractors, system integrators (Siemens, Honeywell, Rockwell, etc.) and the client’s validation/qualification team.
·        Verify adherence to the Project Quality Plan (PQP), Site Quality Plan (SQP) and Inspection Test Plans (ITPs).
·        Ensure installations meet ATEX and other hazardous area regulations when applicable.
·        Response to Quality Related queries via RFI (Request for Information) from Contractors.
·        Prepare quality control documentation and reports for internal and external audits.
·        Ensure compliance with GDP (Good Documentation Practice), GEP (Good Engineering Practice) and traceability of quality records.
·        Recommend corrective actions or modifications for non-compliant systems or components.
·        Collaborate with engineering and contractors to resolve quality issues.
·        Work closely with QAQC managers, engineers, and contractors to ensure quality objectives are met.
·        Participate in quality meetings and contribute to continuous improvement initiatives.
·        Prepare daily and weekly QC reports, maintain inspection records, and ensure traceability of documentation.

Qualifications & Skills:
Completed vocational training (Techniker, Meister) or Bachelor/ Master in electrical engineering, automation technology, instrumentation or equivalent.
Minimum 5 years of QC/QA experience in pharmaceutical, biotech or life-science projects (greenfield experience is a strong advantage).
Proven hands-on experience with ELV systems and instrumentation in cleanroom/ pharmaceutical environments.
In-depth knowledge of relevant standards and regulations:
– EU-GMP Annex 1 & Annex 11
– GAMP 5
– DIN EN 60204-1, DIN EN 61439 (low voltage)
– IEC 61511 (functional safety – advantageous)
– 21 CFR Part 11 / EudraLex Volume 4; Atex directive 2014/34/EU
Experience in reviewing and approving SAT protocols, calibration certificates (DAkkS/ISO 17025) and loop folders.
Familiar with common platforms: Siemens Desigo/PCS7, Honeywell Experion, Rockwell/Allen-Bradley, Beckhoff, etc.
Fluent in English; German language skills are a strong plus (minimum B1 desired).
·        Good skills in MS Office; experience with EIDA is a plus
Work full-time on-site (Monday to Friday).
Operate effectively in a fast-paced, dynamic construction environment.
Demonstrate a proactive approach to contractor coordination and quality enforcement.