Validation Engineer

2 weeks ago

Philadelphia, United States CareerBuilder Full time

Address: 88 Heckmans Gap Rd, Mill Hall, PA 17751 USA
Requisition: 3566
Be part of our journey
As a global leader in specialty chemicals, we continue to succeedand strengthen our delivery of innovative, sustainable and high-performancesolutions. We are passionate about developing and utilizing new technologies to shape and inspire change within an ever-growingmarketplace.

Overview
Croda is seeking a Validation Engineer to undertake works in supportof the site cGMP validation program to maintain compliance to ICHQ7. Thisindividual will be responsible for oversight, coordination, and implementationof the site Validation Master Plan. Liaising with internal and externalstakeholders to ensure a compliant validated state is maintained. Specificefforts will include the generation, completion, approval and archiving of allrelevant validation documentation. The individual will also be the primarysupport for site validation activities.

Duties and Responsibilities
KEY DUTIES
To coordinate implementation of the Site Validation Master Plan forplant, control systems and computer systems validation to support manufactureon site
Responsibility for the Process Validation program for the site
Responsibility for the Cleaning Validation program for the site
Support of Laboratory and Analytical Method validation programs
Plan, organize and coordinate multiple validation projects on site,both short and long term that will involve coordination with a number ofinternal and external stakeholders
Develop and oversee lifecycle management processes for thedemonstration of continued compliance
To support and deputize for the Head of Quality in matters relatingto validation
To coordinate activities with site departments for the purpose ofgenerating data for site regulatory submissions
To assist with regulators and external customers as required inactivities such as site inspections to relay information with regards tovalidation
Requires a persuasive, tenacious personality, who can transferverbal discussion into written communication, through site validationdocumentation and procedures, ensuring the ensuing systems are implemented andmaintained to a high standard and in compliance with quality and validationrequirements
Manage the knowledge flow of validation information to customers incompliance with commercial contracts
Assistance in generation of Annual Product Quality Reviews
Prepare annual product quality review reports for site products
Write/update and review standard operating procedures
Additional Quality Assurance functions as required
Education and Training
Degree in relevant scientific discipline or equivalent experience
Knowledge and Experience
Knowledge of cGMP, ICH and FDA 210 + 211 guidelines
Knowledge and experience of GAMP5
Knowledge and experience of ISPE guidelines
5+ years validation experience in a pharma environment
Strong working knowledge of validation landscape
SAP experience preferred; but not required
Database use and experience
COMMUNICATION SKILLS
Must have oral & written proficiency in the English language,internally with all functions on site, externally with suppliers, auditors andcustomers
COMPUTER SKILLS
Proficient in MS Office
Knowledge of electronic QMS systems
OTHER SKILLS
Project Management skills
Problem solving skills
Efficient, reliable and competent in self organization skills
Able to work as a team
Physical Demands
Able to walk, sit, or stand for a minimum of 8 hours per day
Croda recognizes employees as our strength and the diversity theybring to our workforce is directly linked to our ongoing success. We are anequal opportunity employer and place a high value on diversity and inclusion atour company. We do not discriminate on the basis of any protected attribute,including age, race, color, religion, national origin, gender, sexualorientation, gender identity, gender expression, marital or veteran status,pregnancy or disability, or any other basis protected under applicable law. Inaccordance with applicable law, we make reasonable accommodations forapplicants' and employees' religious practices and beliefs, as well as anymental health or physical disability needs.
Equal Opportunity Employer/Disability/Veterans. This Organization Participates in E-Verify.

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