CQV Engineer

Position Vacant

CQV Engineer

Organization Name

Elomatic Pharmalab Consulting and Engineering Pvt. Ltd.

Company Profile

Job Description /

Responsibilities

1. Responsible for providing direct services to site Technical Services

management, aiding to increase the throughput of commissioning,

qualification, and validation activities through the department and

across the site.

2. Review site commissioning and qualification documentation for

accuracy, technical soundness and compliance to both site and

regulatory guidelines.

3. Project will include new facilities/equipment startup, commissioning,

FAT, manufacturing equipment qualification, laboratory equipment

qualification and computerized and automation systems including

FMS and BMS systems.

4. Provide support for the development of user requirement and

functional specifications.

5. Support the generation and execution of all commissioning and

qualification documentation related to demonstration batches,

thermal studies, validation studies for equipment, facilities, utilities,

engineering test runs, development studies, software validation and

final reports.

6. Recommends to management as to the acceptance and release of

qualified systems.

7. Actively participates during all phases of validation projects.

Evaluates projects, provides technical information to others.

8. Review technical and quality system documents such as SOPs,

Change Control and Deviation Reports, Batch Production Records,

Technical Manuals, P&IDs, construction, as-built, flow diagrams as

they relate to validation principles and regulatory compliance

issues.

9. Review various documentation and drawings to ensure any

document changes, meet quality and validation requirements and

are in full compliance with regulations and standards.

10. Support, investigate and troubleshoot problems and determine

possible solutions.

11. Preparation of PFD, URS, FDS, Cycle Time Analysis etc.

12. Calculation for Utilities, Peak Loads, Pipe/Pump sizing, Equipment

capacity, and other accessories capacity/load/size

13. Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents

(VMP, FAT, IQ, OQ, PQ etc)

14. Equipment/Instrument Selection, Vendor Evaluation, Techno-

commercial Report Preparation

15. Site execution of validation activities

Desired Skills

Basic requirement:

1. Knowledge of chemical engineering unit operations/processes

2. Knowledge of chemical engineering design calculations

3. Knowledge of AutoCAD (Preferred)

4. Knowledge of various Regulatory / GMP / Statutory requirements

related to Pharmaceuticals & Biotech manufacturing (Preferred)

5. Knowledge of engineering guidelines like ISPE, ASME, ASME-BPE,

ASTM etc

Skills

1. Technically strong (fluid dynamics, Heat & Mass Transfer etc.)

2. Good in literature survey from internet Process, Processing

Machines & components, etc.

3. Understanding of Process Planning, scheduling, Gantt chart

preparation

4. Basic Understanding of SIP/CIP, GMP, Water for Pharmaceutical

Use, Equipment Qualification (Validation), Contamination & Cross-

Contamination etc.

5. Strong written communication skill (mandatory).

6. Excellent problem solving and time management skill.

7. Self-motivated and highly organized

8. Ability to work in groups/as a part of team

9. Maintain performance in demanding situations

Qualification &

Eligibility

BE Chemical / Biochemical/ Biotechnology

5 Years of relevant experience in Pharma and Biotec projects

downstream processes/ Sterile, API, OSD etc.

Process / Design Engineer from Consulting & Engineering

(Pharmaceuticals/Biotech) Companies- Preferred

Process Engineer / Project Engineer from Finished Pharmaceuticals

(Sterile API, Parenteral), Biotech., & Fermentation Industries

Design Engineer from Equipment Manufacturing Companies

Location of Posting

Mumbai