08 Sep
|
PharmNXT Biotech
|
Bhavnagar
08 Sep
PharmNXT Biotech
Bhavnagar
About the Role /n /n We’re looking for a Service Engineer with 2–4 years of experience in the Pharma/Biopharma industry to join our team. The role will be responsible for the installation, qualification, commissioning, and servicing of process and automation systems , including FAT, SAT, and documentation activities. The role involves coordination between process teams, suppliers, and internal departments to ensure smooth execution, compliance, and customer satisfaction. /n /n Responsibilities /n /n /n
- Perform equipment installation, FAT (Factory Acceptance Test), SAT (Site Acceptance Test), and qualification (IQ/OQ/PQ) as per project and regulatory requirements.
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- Coordinate between the process engineering team and equipment suppliers to ensure all technical and process requirements are clearly communicated.
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- Attend customer complaints and provide quick technical support for breakdowns and emergency situations.
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- Support in-house electrical and automation activities, including wiring, panel assembly, and control system testing.
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- Coordinate with vendors during manufacturing stages, advising on design specifications and providing hands-on technical assistance when necessary.
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- Participate in project meetings to provide progress reports, identify risks, and ensure timelines are maintained.
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- Prepare and review Project Engineering (PE) documents, ensuring all revisions and approvals follow document control procedures.
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- Handle document numbering, revisions, and approvals in accordance with company standards.
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- Coordinate with the warehouse for material requests and ensure timely availability of components and spares.
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- Collaborate with the manufacturing and process teams for new product development, testing, and technical evaluation.
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- Ensure compliance with industry codes, electrical safety standards, and department procedures during all activities.
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- Participate in the preparation and implementation of Standard Operating Procedures (SOPs) related to automation, qualification, and installation.
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- Prepare and maintain project-related documents such as FAT/SAT checklists, IQ/OQ protocols, commissioning reports, and CAPA records.
/n /n Follow internal procedures for: /n /n
- Document Control
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- Training and Competency Evaluation
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- Change Management System
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- Handling of Deviations and Investigations
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- Initiation and Implementation of CAPA
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- Provide technical solutions and recommendations to meet customer-specific requirements.
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- Conduct system trials and tests both in-house and at customer sites to ensure functionality and compliance.
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- Support the quality and validation teams during qualification, deviation handling, and audit preparation.
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- Ensure adherence to safety, GMP, and regulatory standards throughout the project life cycle.
/n /n /n Qualifications /n /n Diploma/ B.E / BTech- Electrical/Mechanical/Instrumentation Engineering. /n /n Required Skills /n /n /n
- Understanding of FAT/SAT, IQ/OQ/PQ, CAPA, and documentation standards.
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- Familiarity with UL, CE, ATEX, and IECEx compliance standards.
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- Excellent troubleshooting and analytical skills.
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- Solid coordination, communication, and documentation abilities.
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- Ability to work independently and interact effectively with customers and vendors.
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- Commitment to safety, quality, and continuous improvement.
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📌 Service Engineer (Bhavnagar)
🏢 PharmNXT Biotech
📍 Bhavnagar