POSITION SUMMARY:
The CQV Engineer II is
responsible for supporting and ensuring systems, facilities, and equipment meet
the 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:
· Support to commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
· Initiates, authors, revises, reviews, and completes controlled documents for CQV projects.
· 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.
· Supports development SOPs and review final reports.
· Contact and work with contractors and vendors on assigned projects.
· Mentoring and providing consultation to the client and local team.
· Responsible for managing project activities and timelines.
· Provided status reports of projects to the PSC Project Manager.
· Ability to travel as needed.
· Additional duties and responsibilities may be assigned from time-to-time.
DEMONSTRATED COMPETENCIES:
· CQV Technical Execution – Independently executes and delivers commissioning, qualification, and validation activities across assigned systems and projects.
· 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.
· Collaboration & Mentoring – Supports clients and junior engineers through technical guidance, effective communication, and knowledge sharing.
· 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:
· 5-7 years of applicable work experience in the biomedical and pharmaceuticals industry.
· Min 3 years of expertise in CQV
· Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
· Proficient in developing SOPS, final reports and validation & quality policies.
· Understanding of developing, executing and maintaining CQV procedures and policies.
· Has good understanding and complies to cGMPs and Data Integrity 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.
Skills Required
- Bachelor's degree in Engineering or Life Science
- 5-7 years of applicable work experience in the biomedical and pharmaceutical industry
- At least 3 years of CQV expertise
- Proficiency authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents
- Proficiency developing SOPs, final reports, and validation and quality policies
- Understanding of developing, executing, and maintaining CQV procedures and policies
- Understanding of and compliance with cGMPs and data integrity guidelines
- Strategic thinking, implementation, analytical, and data-to-action planning skills
- Ability to develop and implement marketing and product or service strategies
- Excellent written, oral, presentation, communication, organizational, planning, time-management, and multitasking skills
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
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