Validation Engineer, Manufacturing Equipment

Confidential Company  •  Hauppauge, NY

Less than 5 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/12/17 by Peter Chen
Hauppauge, NY
Less than 5 years experience
Biotech/Pharma
Salary depends on experience
Posted on 08/12/17 by Peter Chen

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 design and specification of cGMP equipment, processes and utilities for biologics Replace design and specification with commissioning, qualification and validation and replace biologics with 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 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 an 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 a 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 remove underlines.
  • 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.
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