Equipment Validation Engineer @ M2S ConsultingIndia

Location: Anywhere in India

Role and Responsibilities:

1) Conduct/Assist in validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
2) Understand and follow validation master plans, process flow diagrams, test cases, or standard operating procedures.
3) Study and follow validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
4) Analyze validation test data to define whether systems or processes have met validation criteria or to identify root causes of production problems.
5) Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
6) Perform validation activities, like protocol creation or testing.
7) Identify deviations from established product or process standards follow SOPs for handling deviations.
8) Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures protocols.
9) Assist in/Perform training of equipment operators or other staff on validation protocols standard operating procedures.
10) Assist in the implementation or scheduling of validation testing with affected departments personnel.
11) Prepare, maintain, or review validation compliance documentation.

The candidate must have thorough knowledge of the following areas (The list is not exhaustive but contains salient functions)
Common requirements:
3-5 years Hands-on Experience in validation/qualification of processing systems, equipment, instruments, utilities and clean environments
Good understanding of development of technical packages (URS, FRS, SOPs), project plans, risk assessments, change controls, validation master plans
System life cycle management/management of GMP controlled documentation
Equipment qualification (IQ/OQ/PQ)
Good Manufacturing Practices
Good Documentation Practices
Compliance to 21 CFR Parts 210,211,11,820 standards
Calibration and verification of equipment
Root Cause Analysis
Process Validation
Method Validation
Swab sampling
Excellent communication skills
Team Player
Familiarity with electronic systems/software applications for documentation, test automation will be an added advantage.

For the Validation Engineer position in manufacturing area, the candidate should have enough first-hand exposure to manufacturing processes, facilities, equipment used and the validation of these. Below is a sample indicative list:
Industrial scale Balances
Autoclaves
Centrifuges
Refrigerators
Freezers
Stability Chambers
Pumps
Freeze-dryers
Ovens
Sterilizers
Vial filling machines
Mixers/blenders/stirrers
pH meters
Viscometers
Evaporators
Spray dryers
Blister machines
Coating machines
Colloid mill
Compression machines
Fluid Bed Dryer
Rapid mixer granulator
Strip machine
Sifter
Tablet punching machines
Tablet Evaluation machines
Capsule Filling machines
Capping machines
Extrusion equipment
Powder Handling equipment
Powder filling equipment
Feeders/Hoppers
Ampoule filling machines
Liquid filling machines
Syringe filling machines
Metal detectors
X-ray Inspection Systems
Validation processes for HVAC systems
Validation of water systems for pharmaceutical use
Cleaning validation process and methodology

For Validation Engineer position in QC/R&D labs, the candidate should have hands-on experience in the instruments and various validation processes and SOPs involved. He/she should be familiar with Analytical Method Validation Plans, Protocols, Reports and other documentation needs for various tests involving instruments such as the following:
Analytical, Micro Balances
Dissolution apparatus
Electrophoresis
UV spectrophotometers
GC
GC-MS
Refrigerators/freezers
Laminar Flow Hoods
Colony counters
Cell harvesting systems
Fume hoods
Incubators
Shakers
Vacuum Pumps
LC
LC-MS
MS
Microplate readers
IR/NIR spectrometers
Polarimeter
Refractometer
Please email resume at: [Confidential Information]

S. Shekar
Chief Operating Officer
M2S Consulting (India) Private Limited
2nd Floor, Amfotech Park,
Road Number 8, Wagle Estate,
SG Barve Road, Padwal Nagar,
Thane West,
Maharashtra 400604.
M: +91 9833354***
Mail: [Confidential Information]
www.M2S.in