- Develop and formalize an ETOP package that includes flexibility for different Client approaches
- Supports cGMP compliance-based services with Trade Partners and Clients as defined by the Project Scope
- 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
- Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
- Prepare and Review reports, both internally and externally, from Trade Partners for completed CQV, CV, CSV and automation activities
- Review & Approve User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Change controls and equipment, and process Failure Mode and Effects Analysis (FMEA).
- Provide investigational & troubleshooting support encountered during execution activities
- Provides technical training to Client staffing to enhance speed of startup activities
- Collaborate with Market Team Leaders to ensure RFT delivery
- Ability to plan and execute Smoke / Airflow Visualization Studies for both Iso & Non-Iso spaces
- 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 - Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
- 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
- Flexible and willing to travel as needed
- Perform other duties as assigned
- Bachelor's Degree in Architecture, Engineering, or Construction Management, or similar degree preferred, or equivalent years of relevant industry experience.
- 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.
- Demonstrated effective leadership and collaboration skills
- Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects
- Excellent organizational, interpersonal, presentation, and communication skills
- Commitment to technical excellence, as well as creating world-class experiences for our clients and employees
- 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
• Experience writing commissioning test plans, IOQ/PQ Protocols and Validation Protocols - Experience using statistical, risk assessment, and process improvement tools.
- Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator
- 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.
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Senior Project Manager, CQV - Cary, United States - CRB
Description
Job Description
Job DescriptionCompany DescriptionCRB's over 1,500 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.
As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.
Job DescriptionCRB is looking for an energetic, self-motivated individual for the role of CQV, Sr. Project Manager. The Commissioning, Qualification & Validation (CQV) Sr. Project Manager will provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. This leadership and guidance will ensure that our Clients have a Rightthe-First Time (RFT) solution that has mitigated risks and met their compliance and timeline objectives. This position requires a high level of organization, communication, and leadership. The qualified candidate should display excellent interpersonal skills to form strong relationships with internal and external clients. They will represent CRB in a professional manner, assist in winning work, and understand how their strategy directly impacts our collective success.
Responsibilities
Qualifications
All your information will be kept confidential according to EEO guidelines.
CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening.
CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.
CRB offers a complete and competitive benefit package designed to meet individual and family needs.
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.
