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POSITION SUMMARY:
The CQV Engineer II isresponsible for supporting and ensuring systems, facilities, and equipment meetthe design requirements to be put in place for a facility. The incumbent isalso responsible and accountable for the execution of the PSC mission, “tomaintain the integrity and professionalism of our products and services whileenabling steady growth and development.”
DUTIES AND RESPONSIBILITIES:
· Towork alongside the client team's in in commissioning and qualificationactivities that align with the project objectives
· Support to commission, qualify, and validate facilities,utilities, and/or equipment in assigned projects.
· Initiates, authors, revises, reviews, and completescontrolled documents for CQV projects.
· Writes and reviews GMP and GDP documents andtechnical specifications.
· Collaborate with multiple departments onassigned project activities and deliverables.
· Initiate and coordinate risk analyses, designreviews, execute FAT/SAT, IQ, OQ, and PQ.
· Supports development SOPs and review final reports.
· Contact and work with contractors and vendorson assigned projects.
· Mentoring and providing consultation to theclient and local team.
· Responsible for managing project activitiesand timelines.
· Provided status reports of projects to the PSCProject Manager.
· Ability to travel as needed.
· Additionalduties and responsibilities may be assigned from time-to-time.
· Support to commission, qualify, and validate facilities,utilities, and/or equipment in assigned projects.
· Initiates, authors, revises, reviews, and completescontrolled documents for CQV projects.
· Writes and reviews GMP and GDP documents andtechnical specifications.
· Collaborate with multiple departments onassigned project activities and deliverables.
· Initiate and coordinate risk analyses, designreviews, execute FAT/SAT, IQ, OQ, and PQ.
· Supports development SOPs and review final reports.
· Contact and work with contractors and vendorson assigned projects.
· Mentoring and providing consultation to theclient and local team.
· Responsible for managing project activitiesand timelines.
· Provided status reports of projects to the PSCProject Manager.
· Ability to travel as needed.
· Additionalduties and responsibilities may be assigned from time-to-time.
DEMONSTRATED COMPETENCIES:
· RelationshipBuilding – Works with and across formal and informalprofessional and social networks to build long-term partnerships andconnections in the life science industry.
· CQV Technical Execution –Independently executes and delivers commissioning, qualification, andvalidation activities across assigned systems and projects.
· NegotiationSkills – Active listening, needs assessment, andpresents visions to build a consensus.
· AnalyticalSkills – Identifies, researches, and demonstrateslogical reasoning to communicate critical information.
· RationalPersuasion – Presents key factors, influencing factors,and strategic goals to assist stakeholders in identifying solutions.
· Collaboration & Mentoring – Supportsclients and junior engineers through technical guidance, effectivecommunication, and knowledge sharing.
· InterpersonalAwareness – 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 andmultiple tasks under inflexible timelines.
· CQV Technical Execution –Independently executes and delivers commissioning, qualification, andvalidation activities across assigned systems and projects.
· NegotiationSkills – Active listening, needs assessment, andpresents visions to build a consensus.
· AnalyticalSkills – Identifies, researches, and demonstrateslogical reasoning to communicate critical information.
· RationalPersuasion – Presents key factors, influencing factors,and strategic goals to assist stakeholders in identifying solutions.
· Collaboration & Mentoring – Supportsclients and junior engineers through technical guidance, effectivecommunication, and knowledge sharing.
· InterpersonalAwareness – 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 andmultiple tasks under inflexible timelines.
Requirements
REQUIRED EDUCATION AND WORK EXPERIENCE:
· Bachelor’sDegree in Engineering or Life Science.
· 5-7years of applicable work experience in the biomedical and pharmaceuticals industry.
· Min 3 years of expertise in CQV
· Proficientin authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
· Proficientin developing SOPS, final reports and validation & quality policies.
· Understandingof developing, executing and maintaining CQV procedures and policies.
· Hasgood understanding and complies to cGMPs and Data Integrity guidelines.
· Demonstratedstrategic thinking and implementation skills; proven analytical skills withability to translate. data to actionable plans; demonstrated ability to developand implement marketing and product/service. strategies by converting them intotactical marketing plans; execute and deliver results.
· Excellentpresentation and communication skills, written and oral, for a variety ofaudiences.
· Highlyorganized in planning and time management, with the ability to multi-task.
· 5-7years of applicable work experience in the biomedical and pharmaceuticals industry.
· Min 3 years of expertise in CQV
· Proficientin authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
· Proficientin developing SOPS, final reports and validation & quality policies.
· Understandingof developing, executing and maintaining CQV procedures and policies.
· Hasgood understanding and complies to cGMPs and Data Integrity guidelines.
· Demonstratedstrategic thinking and implementation skills; proven analytical skills withability to translate. data to actionable plans; demonstrated ability to developand implement marketing and product/service. strategies by converting them intotactical marketing plans; execute and deliver results.
· Excellentpresentation and communication skills, written and oral, for a variety ofaudiences.
· Highlyorganized in planning and time management, with the ability to multi-task.
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