FCX Performance, Inc Job - 39243195 | CareerArc
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Company: FCX Performance, Inc
Location: Raleigh, NC
Career Level: Mid-Senior Level
Industries: Manufacturing, Engineering, Aerospace

Description

The Commissioning, Qualification, and Validation Senior Engineer reports directly to the Team Leader, Manager, or Director of the CQV Team, depending on the organizational structure. This position is exempt. Up to 100% travel may be required.

Here are some of the benefits we offer:

  • Competitive Pay
  • Bonus Plan for this position
  • Medical, Dental, and Vision Insurance
  • 401k plan with employer contributions
  • PTO/Holiday
  • Employer-paid long-term disability and short-term disability

 

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).

 

In addition to the above, Senior CQV Engineers initiate, develop, and lead CQV projects and teams (internal and at client sites) with both PCI and non-PCI team members. They are accountable for CQV project initiation, inception, design, development, implementation, management, follow up, and maintenance.

 

Responsibilities/Assignments:

Senior CQV Engineer

  • Leads commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments for multiple projects simultaneously
  • Oversees development, review and approval of protocols by internal and external team members for multiple projects simultaneously
  • Oversees initiation, review and approval of controlled documentation and provides client support for CQV projects
  • Oversees development, review and approval of documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports by internal or external team members on multiple projects simultaneously
  • Leads meetings 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.  Expands PCI's scope through scope change or new funded projects with the client
  • Subject Matter Expert.  Oversees reviews of equipment specifications and manuals.  Provides guidance on how systems, equipment and instruments work. Ensures equipment is accurately tested to meet requirements for intended use.  Resolves complex issues with systems, equipment and instruments
  • Oversees failure and deviation investigations and reviews reports.  Resolves complex issues identified during deviation investigations.  Ensures corrective actions and solutions are effective. 
  • Subject Matter Expert on spare parts programs.  Utilizes tools such as FMEA to develop spare parts lists, identify critical spare part requirements and parts levels to ensure reliable maintenance.
  • Oversees reviews of engineering drawings.  Ensures drawing accuracy and approves corrections
  • Supervises multiple teams performing system walk-downs and oversees the change control processes
  • Initiates investigations, resolves complex issues and implements Corrective and Preventative Actions to clients to resolve CAPAs
  • Oversees development of, reviews and approves summary and analyses reports.  Ensures GDP, accuracy and quality of the documents before delivery to the client
  • Subject Matter Expert.  Develops maintenance programs, creates and maintains job plans, maintenance schedules and PMs.  Establishes reliable maintenance program based on Good Engineering Practices and Business Risk
  • Manages multiple project simultaneously to ensure projects are on time, within scope, within budget and meet or exceed customer expectations
  • Identifies and documents scope changes. Initiates meetings, negotiates changes, develops scope clarification documents and obtains approval from customers before execution
  • Interfaces and networks with industry professionals through professional organizations such as ISPE, PDA, NCSL, or ASQ. Shares SME knowledge through presentations, training sessions, or meetings
  • Implements controlled documentation systems in support of CQ projects
  • Manages multiple projects and resources simultaneously
  • Proactively assesses and evaluates situations to initiate, develop and revise design specifications and engineering drawings to establish fit-for-purpose for systems

 

Skills Required:

Senior CQV Engineer

  • Subject Matter Expert with work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations.  Develops programs and procedures to ensure cGMP and regulatory compliance
  • Subject Matter Expert on principles, practices and procedures for commissioning and qualification.  Leads teams in developing and executing commissioning strategies, validation master plans, commissioning test plans
  • Subject Matter Expert with exceptional analytical, organizational, time management and problem-solving skills.  Leads teams.  Develops innovative approaches to resolves complex problems.  Reviews and approves corrective action plans developed by team members.
  • Excellent writing skills.  Reviews and approves DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, SOPs, final reports and validation and quality policies, procedures and guidelines   Ensures documents are accurate and compliant before final approval
  • Subject Matter Expert in working in a construction environment with knowledge, skills and abilities to adhere to current industry guidelines, standards and safety requirements.  Possesses OSHA 30 or higher certification and functions as team foreman or safety representative
  • Subject Matter Expert at reading and interpreting P&IDs. Identifies corrections needed for accurate as-built drawings. Takes action to obtain approval and final signature for as-build drawings
  • Subject Matter Expert for GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines.  Ensures compliance related to qualification of systems and validation of processes.  Reviews and approves programs and procedures and makes recommendations to reduce regulatory compliance risk and to make processes more efficient.
  • Highly skilled with Microsoft Word, Excel, PowerPoint, Visio and Project.  Can create complex formulas, easily manipulate formatting and develop innovative professional presentations to help monitor and control project execution.  Develops project status reports to present to senior leaders and decision makers.
  • Oversees multiple projects simultaneously.  Plans, organizes, monitors and controls project activities to ensure the project is on schedule, within scope, within budget and is meeting customer expectations. 
  • Subject Matter Expert 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.  Reviews and approves validation protocols, including IQ, OQ and PQ documents prior to submission to clients for approval.  Performs quality review of executed protocols to ensure cGMP and GDP compliance prior to submission to clients
  • Subject Matter Expert. Detail oriented.  Plans, organizes and communicates CQV project tasks across multidisciplinary teams for multiple projects simultaneously.  Reviews work efforts and documentation to ensure accuracy. Ensures deliverables and documentation meet or exceed regulatory and customer requirements.
  • Oversees and manages multiple projects simultaneously
  • Exceptional communication skills with ability to tailor messages for senior level leaders
  • Industry expert on regulatory issues and requirements with the ability to apply requirements to systems and processes to ensure compliance

 

 

Experience & Education Required for Senior CQV Engineer:

BS in Engineering, Life Sciences, or equivalent training with four years of relevant project experience, eight years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Subject matter understanding of Quality Systems and the Life Science manufacture industry is required.  Understands and can interpret and apply all regulatory requirements, Engineering Best Practices and ISPE Good Practices.  A current PE license is preferred.

 

Or

 

MS in Engineering, four years of relevant project experience and six years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Subject matter understanding of Quality Systems and the Life Science manufacture industry is required.  Understands and can interpret and apply all regulatory requirements, Engineering Best Practices and ISPE Good Practices.  A current PE license is preferred. A current PE license is preferred.

PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions.  At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2005. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry.

Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers.

 

We are an equal employment opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.


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