POSITION SUMMARY:
The Validation 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:
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
• Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
• Assists to review and qualify equipment for commissioning, qualification, and validation activities.
• Supports to write and review GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on assigned project activities and deliverables.
• Assist to 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.
REQUIRED EDUCATION AND WORK EXPERIENCE:
• Bachelor’s Degree in Engineering or Life Science.
• 2-5 years of applicable work experience in commission, qualify and validating facilities.
• Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Experience developing SOPS, final reports and validation & quality policies.
• Has good understanding and complies to cGMPs, PIC(S) and CFR21 guidelines.
• Strategic agility and action oriented with the ability to drive results.
• Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans and deliver results.
• Strong verbal, technical writing, time management and interpersonal skills are required - 30 minutes will be fine for the interview. Put in 45 minutes just to be safe.
$75,000 - $90,000
The Validation 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:
• Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
• Assists in authors, revises, reviews, and completes controlled documents for CQV projects.
• Assists to review and qualify equipment for commissioning, qualification, and validation activities.
• Supports to write and review GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on assigned project activities and deliverables.
• Assist to 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.
REQUIRED EDUCATION AND WORK EXPERIENCE:
• Bachelor’s Degree in Engineering or Life Science.
• 2-5 years of applicable work experience in commission, qualify and validating facilities.
• Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Experience developing SOPS, final reports and validation & quality policies.
• Has good understanding and complies to cGMPs, PIC(S) and CFR21 guidelines.
• Strategic agility and action oriented with the ability to drive results.
• Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate data to actionable plans and deliver results.
• Strong verbal, technical writing, time management and interpersonal skills are required - 30 minutes will be fine for the interview. Put in 45 minutes just to be safe.
$75,000 - $90,000
