Validation Specialist

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 longterm 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

Bachelor s Degree in Engineering or Life Science.

25 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.

$$75000

Bachelor's Degree in a relevant science or engineering field, or equivalent hands-on experience. 3+ years of experience in the biotechnology and pharmaceutical industries with a minimum of 2 years of relevant experience performing CQV activities within GMP environment. Sound industry knowledge, project proficiency, and autonomy expected. Experienced in validation of facilities/utilities/equipment, including cleaning validation and IQ/OQ/PQ of equipment. Strong understanding of current risk-based validation approaches. Experienced in authoring, revising, reviewing, and completing controlled documents for validation projects. Experienced with risk assessments. Excellent organizational skills. High attention to detail. Strong written and verbal communication skills. Strong knowledge of the code of GMP and PIC/S code. Must be adaptable, customer service oriented, and have a positive attitude. #LI-MS2