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Senior Validation Engineer (1 year contract)

Keywords / Skills : validation, medical

3 - 8 years
Posted: 2018-04-17

Industry
Bio Technology & Life Sciences
Function
Pharmaceutical/ Biotechnology
Role
Quality Assurance Manager
Quality Director
Other Pharma - validation
Education
Bachelors/ Degree
Posted On
17th Apr 2018
Job Description
Responsibilities:
 Leading and managing new site facility and process qualification

 Working with facility engineer and manufacturing engineers and product quality engineer on establishing qualification requirement, schedule, protocol ( IQ, OQ, PQ), acceptance criteria at new factory

 Support manufacturing engineers perform qualification on newly duplicated equipment

 Assisting manufacturing engineers execute qualification plan per timeline

 Working with facility engineer and manufacturing engineers compiling the qualification report 
 Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters

 Oversight of validation activities for trials and product migration

 Support engineering testing /trials and requirements for final product changes

 Creation, review, and update of risk analysis for changes and new processes that impact products

 Perform statistical analysis related to process validation 
 Provide inputs in validation and regulatory requirement for current direct impact equipment, new equipment, and processes
Requirements:
 Bachelor’s Degree in an Engineering discipline or equivalent

 Minimum 7 years of Process Validation experience in Pharmaceutical, Medical Device or Parenterals. Experience in FDA or ISO Regulated Industry is a must.

 Prior experience in working on site transfer or new facility setup is preferred

 FDA Process Validation Guidance, Statistical Sampling, Technical Writing, Use of MiniTab, product validation

 Demonstrated experience and proficiency with cGXP, ICH and PIC/S. Experience with regulatory and/or third party audits is a plus

 Awareness of ISO 9000 / ISO13485

 Strong knowledge of Process Validation, Project Management, Multi-tasking, Intermediate Statistics Knowledge (sampling plans, hypothesis testing, etc)

 Strong Verbal and Written Communication

Jocelyn Ho Wen Mun (R1658156)
jocelyn.ho@searchasia.com.sg 

Key Skill(s)

About Company

A TRADITION OF EXCELLENCE WITH A VISION OF TOMORROW

SearchAsia believes that hiring good people is the key to every organization’s success. They grow and go through adversities with the organization. Winning organizations are those which are able to attract, develop and retain good people.

At SearchAsia, we are in the people business. We have a natural flair for anticipating and understanding your needs. Deploying our unique Total System Approach, our recruitment experts in the various practices reach deep into their specializations to deliver a one-stop solution to your hiring needs.

We believes in cultivating a strong entrepreneurial ethos in the company. Diligence, discipline and integrity are some of our defining values, along with agility and a focus on elevating lives and impacting businesses.
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