Description:
POSITION SUMMARY :
The Senior Commissioning, Qualification, and Validation (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.”
DUTIES AND RESPONSIBILITIES:
- 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.
DEMONSTRATED COMPETENCIES:
- Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
- Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus .
- Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
- Rational Persuasion – Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions .
- Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
- Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Requirements
REQUIRED EDUCATION AND WORK EXPERIENCE:
- 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.
26 Feb 2025;
from:
uworkin.com