PharmNXT Biotech
Website:
pharmnxtbiotech.com
Job details:
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.
- Strong coordination, communication, and documentation abilities.
- Ability to work independently and interact effectively with customers and vendors.
- Commitment to safety, quality, and continuous improvement.
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