Associate Validation Specialist

Catalent•Winchester, KY

1d•Onsite

About The Position

The Associate Validation Specialist position shall provide validation support and oversite of activities in facility, utility, and equipment qualifications. The Associate Validation Specialist is responsible for validation activities, including drafting and approving documents, execution of protocols on the manufacturing floor, drafting reports, attending customer meetings, supporting customer audits to provide validation support and to ensure they meet manufacturing timelines and to maintain compliance.

Requirements

HS Diploma required with 2+ years experience in Pharmaceutical/ Biotechnology or Medical Devices industry. Associate’s Degree required when individual has no experience in the Pharmaceutical/ Biotechnology or Medical Devices industry.
Experience in authoring, reviewing and approving of validation deliverables including Risk Assessments, Test Plans, Protocols, Reports, Summary Reports and Standard Operating Procedures (SOPs).
Must have working knowledge of GxP, regulatory requirements for pharmaceutical industry (i.e. 21 CFR part 11)
Must have good documentation practices.
Working knowledge of cGMP guidelines and regulations
Working knowledge of TrackWise and EDMS systems.
Knowledge of validation SOPs and site quality policies
Requires excellent computer skills and general knowledge of computerized systems, and scientific writing skills
Excellent organizational skills
Ability to interact and communicate with all departments / customers in person and on teleconferences.
Proficient in English verbal and written communication skills
Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint)
Ability to work effectively under pressure to meet deadlines
Individual may be required to sit, stand, walk for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor

Responsibilities

Meet with project managers to understand receipt/startup/manufacturing timelines and coordinate/perform validation activities in their area to meet these timelines
Direct facility and equipment validation activities; including facility and equipment risk assessments with review / approval of the facility and equipment change controls.
Direct facility and equipment validation activities; including authoring specifications and protocols and executing validation documentation for facility and equipment in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes specifications, protocols, reports and risk assessments.
Direct validation activities; including execution of protocols on the manufacturing floor, collection of samples and tracking samples through to testing.
Direct validation activities; including conducting periodic validation reviews for equipment and computerized systems.
Support of customer and agency audits with facility and equipment validation documentation and speaking to the data provided.
Assist in process development (NPIx), process validation and continued process verification efforts related to authoring and executing specifications and validation documentation for equipment/systems and processes in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes NPIx development protocols/reports, Process Validation protocols/reports, Continued Process Verification (CPV) plans/reports, Risk Assessments, and Annual Product Reviews (APRs).
Performs qualification activities in line with the project schedules and timelines.
Supports customer and agency audits.
Other duties as required in support of Catalent Pharma Solutions high performance