Senior Project Manager, CQV

Overview

Senior manager overseeing commissioning, qualification & validation projects for life‑science clients.

Key Responsibilities

• fat support
• system requalification
• cqv documentation
• risk assessment
• cgmp compliance
• client training

Tasks

-Support, train, mentor, and provide guidance to commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects -Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns -Collaborate with Market Team Leaders to ensure RFT delivery -Provide investigational & troubleshooting support encountered during execution activities -Prepare and Review reports, both internally and externally, from Trade Partners for completed CQV, CV, CSV and automation activities -Develop and formalize an ETOP package that includes flexibility for different Client approaches -As a subject matter expert, represent these activities in discussions and communications with Clients and regulatory agencies -Responsible for the implementation and execution of the periodic system reviews and requalification activities, as needed -Provides technical training to Client staffing to enhance speed of startup activities -Supports cGMP compliance-based services with Trade Partners and Clients as defined by the Project Scope -Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach. -Review & Approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA). -Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans

Requirements

• commissioning
• qualification
• validation
• cgmp
• kaye validator
• 8+ years

What You Bring

-Flexible and willing to travel as needed -Interpersonal and leadership skills necessary to communicate clearly,and effectively manage qualification/validation activities with all levels of personnel from various disciplines across the organization. -Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects -Bachelor’s Degree in Architecture, Engineering, or Construction Management, or similar degree preferred, or equivalent years of relevant industry experience. -Excellent organizational, interpersonal, presentation, and communication skills -Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations, ISPE Baseline Guide 5 Commissioning and Qualification and ISPE Guideline Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011 -Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator -Experience writing commissioning test plans, IOQ/PQ Protocols and Validation Protocols -Demonstrated effective leadership and collaboration skills -Experience using statistical, risk assessment, and process improvement tools. -8 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of both US and global regulatory requirements. Proficient in cGMP and SUPAC standards. -Ability to plan and execute Smoke / Airflow Visualization Studies for both Iso & Non-Iso spaces

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About Crb

-Global design-build and consulting firm with international offices. -Integrating engineering, architecture, construction, and consulting. -Projects include biopharma facilities, processing plants, and research campuses. -Unified ONEsolution model streamlines design and construction delivery. -From a basement start to delivering high-tech labs and large-scale breweries globally.

Sector Specialisms

Security Clearance

-employment is contingent on background screening.