Validation Engineer

　　Location: Lamar, PA

　　Address: 88 Heckmans Gap Rd, Mill Hall, PA 17751 USA

　　Requisition: 3566

　　Be part of our journeyAs a global leader in specialty chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable and high-performance solutions. We are passionate about developing and utilizing new technologies to shape and inspire change within an ever-growing marketplace.

　　OverviewCroda is seeking a Validation Engineer to undertake works in support of the site cGMP validation program to maintain compliance to ICHQ7. This individual will be responsible for oversight, coordination, and implementation of the site Validation Master Plan. Liaising with internal and external stakeholders to ensure a compliant validated state is maintained. Specific efforts will include the generation, completion, approval and archiving of all relevant validation documentation. The individual will also be the primary support for site validation activities.

　　Duties and Responsibilities

　　KEY DUTIESTo coordinate implementation of the Site Validation Master Plan for plant, control systems and computer systems validation to support manufacture on siteResponsibility for the Process Validation program for the siteResponsibility for the Cleaning Validation program for the siteSupport of Laboratory and Analytical Method validation programsPlan, organize and coordinate multiple validation projects on site, both short and long term that will involve coordination with a number of internal and external stakeholdersDevelop and oversee lifecycle management processes for the demonstration of continued complianceTo support and deputize for the Head of Quality in matters relating to validationTo coordinate activities with site departments for the purpose of generating data for site regulatory submissionsTo assist with regulators and external customers as required in activities such as site inspections to relay information with regards to validationRequires a persuasive, tenacious personality, who can transfer verbal discussion into written communication, through site validation documentation and procedures, ensuring the ensuing systems are implemented and maintained to a high standard and in compliance with quality and validation requirementsManage the knowledge flow of validation information to customers in compliance with commercial contractsAssistance in generation of Annual Product Quality ReviewsPrepare annual product quality review reports for site productsWrite/update and review standard operating proceduresAdditional Quality Assurance functions as required

　　Education and TrainingDegree in relevant scientific discipline or equivalent experienceKnowledge and ExperienceKnowledge of cGMP, ICH and FDA 210 + 211 guidelinesKnowledge and experience of GAMP5Knowledge and experience of ISPE guidelines5+ years validation experience in a pharma environmentStrong working knowledge of validation landscapeSAP experience preferred; but not requiredDatabase use and experience

　　COMMUNICATION SKILLSMust have oral & written proficiency in the English language, internally with all functions on site, externally with suppliers, auditors and customers

　　COMPUTER SKILLSProficient in MS OfficeKnowledge of electronic QMS systems

　　OTHER SKILLSProject Management skillsProblem solving skillsEfficient, reliable and competent in self organization skillsAble to work as a team

　　Physical DemandsAble to walk, sit, or stand for a minimum of 8 hours per day

　　Croda recognizes employees as our strength and the diversity they bring to our workforce is directly linked to our ongoing success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including age, race, color, religion, national origin, gender, sexual orientation, gender ident ty, gender expression, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.Equal Opportunity Employer/Disability/Veterans.   This Organization Participates in E-Verify.