Senior CQV Engineer: GMP Validation & Commissioning Lead

PSC Biotech® Corporation; Melbourne; On-site; AUD 100,000 - 130,000; Full time

Job summary

PSC Biotech® Corporation is seeking a Senior Commissioning, Qualification, and Validation (CQV) Engineer in Melbourne for a 12-month contract. The role entails leading CQV functions and ensuring adherence to design requirements for systems and facilities. Candidates should have 7-10 years' experience in the biomedical field, be proficient in various CQV documentation, and possess excellent communication skills. This position offers an opportunity to work in a dynamic environment focused on maintaining product integrity.

Qualifications

• 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
• Strong experience creating and maintaining CQV policies and processes.
• Demonstrated strategic thinking and implementation skills.

Responsibilities

• Act as a lead and simplify CQV functions and processes.
• Commission, qualify, and validate facilities, utilities, and equipment.
• Collaborate with multiple departments on assigned projects.

Skills

DQ, FAT, SAT, IQ, OQ, PQ documentation

SOP development

CQV protocol development

cGMP and CFR21 compliance

Analytical skills

Communication skills

Education

Bachelor’s Degree in Engineering or Life Science

Job description

We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The Senior CQV Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

• Act as a lead and simplify CQV functions, reports, and processes.
  
• Support implementing safety programs for major capital projects.
  
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
  
• Initiates, authors, revises, reviews, and completes controlled documents for CQV projects.
  
• Review and qualify equipment for commissioning, qualification, and validation activities.
  
• Writes and reviews GMP and GDP documents and technical specifications.
  
• Collaborate with multiple departments on assigned project activities and deliverables.
  
• Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
  
• Contact and work with contractors and vendors on assigned projects.
  
• Ability to travel as needed.
  
• Additional duties and responsibilities may be assigned from time-to-time.
  
  
  
  

POSITION SUMMARY:

We are looking for a Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The Senior CQV Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

• Act as a lead and simplify CQV functions, reports, and processes.
  
• Support implementing safety programs for major capital projects.
  
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
  
• Initiates, authors, revises, reviews, and completes controlled documents for CQV projects.
  
• Review and qualify equipment for commissioning, qualification, and validation activities.
  
• Writes and reviews GMP and GDP documents and technical specifications.
  
• Collaborate with multiple departments on assigned project activities and deliverables.
  
• Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ,
  
• Contact and work with contractors and vendors on assigned projects.
  
• Ability to travel as needed.
  
• Additional duties and responsibilities may be assigned from time-to-time.
  
  
  
  

Requirements

• Bachelor’s Degree in Engineering or Life Science.
  
• 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
  
• Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
  
• Proficient in developing SOPS, final reports and validation & quality policies.
  
• Strong experience developing and executing CQV protocols.
  
• Strong experience creating and maintaining CQV policies and processes.
  
• Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines.
  
• Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate. Data to actionable plans; demonstrated ability to develop and implement marketing and product/service. strategies by converting them into tactical marketing plans; execute and deliver results.
  
• Excellent presentation and communication skills, written and oral, for a variety of audiences.
  
• Highly organized in planning and time management, with the ability to multi-task.