Vacancy caducado!
Validation EngineerLocation: Lamar, PAAddress:88 Heckmans Gap Rd, Mill Hall, PA 17751 USARequisition: 3566Be part of our journey
As 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.Overview
Croda 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 ResponsibilitiesKEY DUTIES
To coordinate implementation of the Site Validation Master Plan for plant, control systems and computer systems validation to support manufacture on 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 of internal and external stakeholders
Develop and oversee lifecycle management processes for the demonstration of continued compliance
To support and deputize for the Head of Quality in matters relating to validation
To coordinate activities with site departments for the purpose of generating data for site regulatory submissions
To assist with regulators and external customers as required in activities such as site inspections to relay information with regards to validation
Requires 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 requirements
Manage the knowledge flow of validation information to customers in compliance 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 requiredEducation 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 experienceCOMMUNICATION SKILLS
Must have oral & written proficiency in the English language, internally with all functions on site, externally with suppliers, auditors and customersCOMPUTER SKILLS
Proficient in MS Office
Knowledge of electronic QMS systemsOTHER SKILLS
Project Management skills
Problem solving skills
Efficient, reliable and competent in self organization skills
Able to work as a teamPhysical Demands
Able to walk, sit, or stand for a minimum of 8 hours per dayCroda 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.
Vacancy caducado!