Senior Project Manager CQV
Senior Project Manager CQV
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Salary Not Disclosed
1 Vacancy
Job Description
CRB is looking for an energetic selfmotivated 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 RighttheFirst 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
- Develop and formalize an ETOP package that includes flexibility for different Client approaches
- Supports cGMP compliancebased 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 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 & NonIso spaces
- As a subject matter expert represent these activities in discussions and communications with Clients and regulatory agencies Responsible for the implementation and 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 riskbased 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
Qualifications :
Qualifications
- Bachelors 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 worldclass experiences for our clients and employees
- Knowledge of US FDA 21 CFRand EU EMEA regulations ISPE Baseline Guide 5 Commissioning and Qualification and ISPE Guideline Science and Riskbased 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 clearlyand effectively manage qualification/validation activities with all levels of personnel from various disciplines across the organization.
Additional Information :
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
