Summary of the role
As the Validation Engineer, you are accountable for driving results in a fast-paced environment by executing the Site’s Validation Program supporting the introduction of new systems, or modification of existing systems such as equipment, critical utilities, facilities, process and computer systems used to manufacture APIs. The position is also responsible for periodic equipment reviews and CTC mappings throughout the asset life cycle. The Validation Engineer will establish validation protocols and procedures ensuring compliance with global regulations and company standards.
Provides validation support for the introduction of new equipment or modification of equipment used to manufacture new APIs.
Assists with the development of such documents as: Validation Master Plans (VMP), Computerized System Validation (CSV), System Design Specifications (SDS), Users Requirements Specifications (URS), and Detailed Design Specifications (DDS).
Designs validation test plans.
Authors, executes and follows up closure documentation for FAT, SAT, Installation (IQ) Operational (OQ) and Performance Qualifications (PQ).
Performs review, authors and revisions of Standard Operating Procedures (SOPs) and related manufacturing process documentation.
Prepares summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode & effect analysis (FMEA), traceability matrices.
Author or Review, Approve Periodic Reviews for manufacturing equipment to evaluate the validated state of the equipment.
Reviews and approves Mapping/(Re) Qualification of Controlled Temperature Units such as Dryers, Ovens, Freezers and Warehouses.
Ensures that the systems associated with manufacturing process remain in a validated state by reviewing the changes made throughout their validation life cycle.
Performs deviation investigations, and executes duties related to the documentation and follow up to Corrective Preventative Action (CAPA) plans and Change Controls (CC).
Responsible for creating validation project and validation progress metrics /KPIs.
Embodies our company values, which are: be reliable, be caring, be transparent and be willing.
Requirements for the role
Bachelor’s degree in Engineering (Mechanical or Chemical preferred) with coursework in Quality, Chemistry, or related field and a minimum of 4-years of experience in the Commissioning & Qualification / Validation of processing equipment, facilities, process, computer systems, critical and support utility systems used for manufacturing small molecule Active Pharmaceutical Ingredients, drug substances or pharmaceutical products.
Experience in HVAC validation and in the design, execution and closing of validation protocols beneficial.
Previous experience with validation of process control systems and trained in Good Manufacturing Procedures (GMP), Good Laboratory Procedures (GLP), and Good Automated Manufacturing Practices (GAMP) highly desirable.
Knowledge in Lean Six Sigma and statistical analysis beneficial.
How you will be rewarded
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
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