Engineer – Validation

Job Description / Responsibilities

1. Preparation of PFD, URS, FDS, Cycle Time Analysis etc.
2. Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents (VMP, FAT, IQ, OQ, PQ, etc) 
3. Site execution of validation activities (SAT, IQ, OQ, PQ)

Desired profile of the candidate 

Basic requirement:

1. Knowledge of chemical engineering unit operations/processes
2. Knowledge of Water system validation.
3. Knowledge of Water Pretreatment, PW generation, WFI generation, Pure steam generation & PW, WFI & PS distribution loops.
4. Knowledge of various Regulatory / GMP / Statutory requirements related to clean utility generation systems.
5. Knowledge of engineering guidelines like ISPE, ASME, ASME-BPE, ASTM, etc. 
6. Ready to travel extensively.
7. Willing to stay on-site for extended durations.
8. Knowledge of AutoCAD (Preferred)

Skills

1. Strong verbal and written communication skill.
2. Can handle client communication directly.
3. Excellent problem solving and time management skill.    
4. Self-motivated and highly organized.                  
5. Can handle assignments independently.   
6. Ability to work in groups/as a part of heterogeneous team.
7. Maintain performance in demanding situations.

UG / PG Qualification

• BE-Chemical Engineering / Mechanical Engineering 
• M.Pharma/ M.Sc. (Chemistry/ Biochemistry)

Minimum Experience

Desired exposure/ hands-on experience include:

• Engineering & Consultancy – Water systems / Pharmaceuticals
• QA (Validation Experts) – Water systems/ Formulations / Biotech Facilities

Desired Exp:

• 5 – 6 years (in case of B.E.)
• 4 – 5 years (in case of M. Pharma/ M/Sc.)
• Process Engineering/ Design know-how will be an added advantage for the M. Pharma/ M.Sc. candidates.
• M.Pharma/ M.Sc. candidates with Diploma in engineering will be given preference

Location of posting

Chennai, Tamil Nadu 

Osaamisalue: Farmasia & lääketeollisuus