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