3 Years Contract Process Engineer - BIOPHARMA MANUFACTURING PLANT

Recruit Express Pte Ltd| Date Posted: 7-Jan-2021
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Permanent, Contract
Position Level:
Experienced
Job Category:
Qualification:
Bachelor's / Honours

Job Description

Responsibilities

  • Work with Design and Construction Management firms (EPCM), together with process engineers to support and complete following tasks within schedule;
  • Involve in Basic and Detail design phase of project.
  • Review P&IDs, standard detail drawings, URS, HAZOP study report etc.,
  • Review 3D model and 2D layouts as appropriate, general arrangement and isometric drawings for construction & installation
  • Review detailed specification datasheets for equipment, valves, instruments, piping etc.,
  • Review testing and commissioning procedures
  • Involve Factory Acceptance Testing (FAT) of all process equipment’s.
  • Involve Inspection Site installation of new equipment’s upon delivery.
  • Review of Vendor Turnover Packages and Construction Trade Turnover Packages.
  • Involve in Design Qualification.
  • Review Functional specifications
  • Participate in Software FAT using PCS7.
  • Involve Commissioning and Qualification of new equipment’s in the Downstream (Purification) areas. Which include reviewing of C&Q documents
  • Review Punch list and follow-up until successful handover.
  • Review hand-over records
  • Coordinates with multi-disciplinary team like Automation, Manufacturing, PDTS and Validation for improvements or implementing changes associated with projects.
  • Responsibility to adhere to any applicable EHS requirements.

 

Education and Experience Requirements

  • 3 to 5+ years of experience in Downstream bioprocess operations and Demonstrated experience in equipment design in Pharmaceutical/biopharmaceutical industry
  • Experience in an engineering role supporting cGMP operations in a Pharmaceutical/biopharmaceutical manufacturing plant is highly desirable.
  • Experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
  • Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.

 

Key Skills and Competencies

  • Process and equipment knowledge of biological drug substance manufacturing processes; downstream unit operations expertise highly preferable
  • Read &Understand PCS7 Functional Specification and Knowledge/ Experience in Siemens PCS7 is preferable.
  • Knowledge/ Experience in DeltaV, is an added advantage
  • Understanding equipment commissioning, various stages of qualification and process activities.
  • Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP)
  • A good understanding of design principles and standards within the biopharmaceutical facilities.
  • Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment’s.
  • Ability to effectively communicate via writing and oral communication at all levels.

 

Interested candidates please submit your resume to [Click Here to Email Your Resume]

 

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)

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