Job description

Job Position: Validation Engineer
Job Location: Germantown, WI
Job Type: Full Time(On Site)
Salary: (Depend Upon Experience)

Your Responsibilities

• 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.

Job Type: Full-time

Pay: From $60,000.00 per year

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Germantown, WI 53022: Reliably commute or planning to relocate before starting work (Required)

Experience:

• HVAC Validation: 4 years (Required)
• Lean Six Sigma: 1 year (Required)
• Validation: 4 years (Required)

Work Location: In person

Speak with the employer
+91 9724727947

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