CQV Engineer II

FCX Performance•Raleigh, NC

About The Position

The Commissioning, Qualification, and Validation Engineer II report directly to the Team Leader, Manager, or Director of the CQV Team, depending on the organizational structure. These positions are exempt. Up to 100% travel may be required. Expectations: The CQV Engineer and Engineer II performs commissioning, qualification, and validation testing on manufacturing process equipment and instruments, authors protocols, initiates controlled documentation, and provides client support for CQV projects either independently or as part of a larger team. Responsibilities may include generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and development and development of final reports. The position requires extensive interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements. CQV Engineers take a proactive role in supporting CQV projects and in providing client support. They build a high level of trust with internal and client personnel. This trust is developed through consistently upholding PCI Values and demonstrating Integrity, Accountability, Unified Team (Teamwork), and Creativity (Innovation).

Requirements

In-depth understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations.
Reviews requirements and enforces procedures to ensure cGMP and regulatory compliance
Possesses an in-depth understanding of principles, practices and procedures for commissioning and qualification.
Can develop commissioning test plans independently or with minimal assistance
Excellent analytical, organizational, time management and problem-solving skills.
Can develop problem statements, identify root causes and create corrective actions to be executed within a prescribed timeline independently.
Assists junior associates in developing analytical, organizational, time management and problem-solving skills
Experienced writer.
Develops and executes DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, develops SOPs, creates final reports and authors validation and quality policies, procedures and guidelines independently or with minimal supervision.
Reviews documents developed by junior members.
Ensures documents are accurate and compliant
In-depth understanding of working in a construction environment with knowledge, skills and abilities to adhere to current industry guidelines, standards and safety requirements.
Possesses OSHA 10 or higher certification
Highly proficient at reading and interpreting P&IDs. Works with Sr CQV Engineer to correct as-built drawings
In-depth understanding of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes.
Develops programs and procedures to comply with regulatory requirements.
Highly skilled with Microsoft Word, Excel, PowerPoint, Visio and Project.
Can create formulas, change formatting and develop professional presentations to help monitor and control project execution and to develop project status reports
Leads project teams.
Plans, organizes, monitors and controls project activities to ensure the project is on schedule, within scope, within budget and is meeting customer expectations.
Highly experienced with validation in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000, Ellab E-Val Pro or other validators and various temperature and relative humidity loggers.
Identifies client requirements and develops, routes for approval and executes validation protocols, including IQ, OQ and PQ documents
Detail oriented with ability to plan, organize and communicate CQV project tasks across a multidisciplinary team.
Reviews work efforts and documentation to ensure accuracy.
Provides training to reduce errors and improve accuracy
Leads teams and provides direction to others
BS in Engineering, two years of relevant project experience and six years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience.
In-depth knowledge of Quality System and the Life Science manufacture industry is required.
Understands and follows all regulatory requirements, Engineering Best Practices and ISPE Good Practices
Or MS in Engineering, two years of relevant project experience and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience.
In-depth knowledge of Quality System and the Life Science manufacture industry is required.
Understands and follows all regulatory requirements, Engineering Best Practices and ISPE Good Practices

Responsibilities

Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments independently or with minimal assistance from others
Authors, reviews and approves protocols
Initiates and reviews controlled documentation for final approval and provides client support for CQV projects independently or with minimal assistance
Develops and reviews documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports
Interacts with clients to identify CQV needs.
Plans, recommends and implements solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices
Reviews equipment specifications, manuals, and has an in-depth understanding of how systems, equipment and instruments work.
Tests equipment accurately to meet requirements for intended use.
Identifies solutions to system, equipment and instrument issues
Initiates failure and deviation investigations and reports.
Recommends corrective actions and solutions
Develops spare parts lists to ensure they are fit for purpose.
Recommends critical spare part requirements and levels with the assistance of the Sr. CQV Specialist or Sr. CQV Engineer
Reviews engineering drawings for accuracy and acts to correct errors independently or with minimal assistance
Leads teams to perform system walk-downs and initiates the change control processes
Initiates investigations and develops Corrective and Preventative Actions to clients to resolve CAPAs independently or with minimal assistance
Develops and reviews summary and analyses reports independently or with minimum assistance
Creates and maintains job plans, maintenance schedules and PMs independently or with minimal assistance
Initiates projects independently or with minimal assistance.
Provides direction and execution instructions to team members and follows up on project deliverables to ensure project success
Identifies and documents scope changes and obtains approval from customers before execution