Validation Engineer, Manufacturing Equipment

Validation Engineer, Manufacturing Equipment

Contract

Company Overview :

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description :

• The Equipment Validation Engineer (Process Equipment) is responsible for site-based engineering and validation support for CGMP cream & ointment process equipment and packaging lines and controls and automation qualification.
• Support / lead the commissioning, qualification and validation of cGMP equipment, processes and utilities for cream and ointment products.

Responsibilities :

• Create, execute validation protocols and write validation summary reports.
• Create validation documents like Functional Risk Assessments, Validation and Qualification Plans, Trace Matrix etc.
• Create and review project documentation (URS, FRS, Technical Specifications, Functional Specifications).
• Manage and populate equipment lists and equipment data sheets.
• Liaise with client end user groups to ensure correct specification of equipment and utilities.
• Create Technical Specification and Functional Specification for automated and manual equipment.
• Should have experience in commissioning, qualification and validation of clean utility systems (RODI, PW, WFI, Clean Steam, Clean Compressed Air), HVAC and Environmental, Packaging Lines, Controls and Automation, Process Equipment etc.
• Provide engineering expertise and drive technical decisions as an active member.
• Perform HAZOP's and risk assessment.

Requirements :

• Bachelor’s degree in Engineering or related field and 3+ years of experience in a FDA regulated industry.
• Need to have experience working in oral solid dosage, liquid, cream & ointments manufacturing plants.
• Familiarity with process design and operation.
• Familiarity with engineering project management, engineering and CQV.
• Understanding of manufacturing and packaging processes in cream and ointment manufacturing facilities.
• Familiarity with qualification and validation of automated (PLC) and Computerized Process Equipment and Systems.
• Excellent knowledge of ASME BPE, ISPE and FDA cGMP requirements.
• Industry experience related to cGMP drug manufacturing, validation, and chemical process design.
• Knowledge of computerized scheduling and spreadsheet software, planning and organizational skills.
• Good oral and written skills, good organizational skills.
• Knowledge of cGMP procedures and validation protocols.

All your information will be kept confidential according to EEO guidelines.

J-18808-Ljbffr