Validation specialist - Sterile exp from pharma manufacturing environment

Sterile
Full Time
Depends on Experience

Job Description

Client will help with relocation

Sterile exp

Key Responsibilities:

  • Qualification of Oral Solid Dose (OSD) and Sterile manufacturing facilities.
  • Maintain all documentation pertaining to qualification and validation.
  • Experience in Equipment and Facility Validation and / or Qualification in GMP environment. This position will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
  • Responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment. This includes FATs, URSs, DQs, SATs, CTPs, IQs, OQs, PQs, PVs and other validation life cycle document
  • Generate equipment/cleaning validation documents.
  • Develop validation and qualification protocols and reports for the Facility, Manufacturing Processes, Manufacturing Equipment, Packaging Equipment, Packaging Processes, Utilities and Cleaning verifications and validation for all equipment and products.
  • Develop/review requirements and specifications.
  • Able to follow-up and resolve comments, deviations, and technical issues.
  • Generate/execute variety of commissioning and qualification protocols for pharmaceutical equipment(IQ, OQ, PQ).
  • Must be able to work independently and in team environment.
  • Must be able to lead project with minimal supervision.
  • Coordinate the proper approval of plans, requirements, and protocols.
  • Review completed protocols for completeness, cGMP compliance and data acceptability.
  • Prepare validation summary and final reports.
  • Collaborates with various engineering system owners such as process, packaging, and automation to reduce product cost and increase productivity while sustaining or improving the validated systems.
  • Develop a strong documentation package, involving form conceptual study to various phases of projects like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
  • Qualification and documentation related to engineering department.
  • Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.
  • Contribute to department efficiency initiatives

Education:

  • Bachelor's degree in relevant scientific discipline required
  • Equivalent experience will be considered

Experience:

  • 3-7 years of experience
  • Hands-on experience in conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.
  • Experience in developing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, safety analysis etc of biopharmaceutical processes.
  • Demonstrated experience with process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, CIP/SIP sequences.
  • Experience reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation.
Dice Id : comrise
Position Id : 6680897
Originally Posted : 4 months ago
Have a Job? Post it

Similar Positions