loader image

Lead CQV Engineer

Date Posted: February 22, 2024

Job Description

We are seeking a highly skilled and experienced Lead CQV Engineer to oversee and manage the commissioning, qualification, and validation activities within our organization. The ideal candidate will be responsible for ensuring that all systems, equipment, and processes meet the required specifications, standards, and regulatory requirements. This role involves leading a team of CQV engineers, coordinating with project managers, and liaising with clients and regulatory bodies to ensure project success.

Key Responsibilities

  • Lead and manage CQV projects from inception to completion, ensuring they are completed on time, within budget, and in compliance with regulatory standards.
  • Develop and implement CQV strategies, plans, and protocols in accordance with industry best practices and regulatory requirements.
  • Oversee the commissioning of new equipment and systems, ensuring they meet operational specifications.
  • Lead the qualification of equipment, facilities, and utilities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
  • Manage the validation of processes and systems to ensure consistent, high-quality outcomes, including but not limited to cleaning, sterilization, and manufacturing processes.
  • Collaborate with cross-functional teams, including engineering, quality assurance, and production, to facilitate seamless CQV activities.
  • Provide technical leadership and mentorship to CQV engineers and technicians.
  • Prepare and review CQV documentation, including plans, protocols, and reports, ensuring thorough documentation of all CQV activities.
  • Act as the primary point of contact for CQV-related communications with clients, regulatory inspectors, and other stakeholders.
  • Stay abreast of industry trends, innovations, and regulatory changes related to CQV and apply this knowledge to continuous improvement initiatives.

Required Qualifications and Skills

  • Bachelor’s degree in Engineering, Life Sciences, or related field.
  • Minimum of 8 years of experience in CQV within the pharmaceutical, biotechnology, or related industry, with at least 3 years in a leadership role.
  • In-depth knowledge of GMP (Good Manufacturing Practices), regulatory requirements, and industry standards related to CQV.
  • Proven track record of successfully leading CQV projects and teams.
  • Strong technical writing and communication skills, with the ability to produce clear and concise documentation and reports.
  • Excellent problem-solving, organizational, and leadership skills.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple projects simultaneously.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

Apply for this position

Allowed Type(s): .pdf, .doc, .docx