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Commissioning, Qualification and Validation Engineer - FCX/PCI - Raleigh, NC (Raleigh, NC, US, 27617)

Job Description

Expectations:

­

The CQV Engineer 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 Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.

Responsibilities/Assignments:

CQV Engineer

  • Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments
  • Authors protocols, initiates controlled documentation in support of CQV projects
  • Provides project planning, management, execution, and follow up
  • Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
  • Investigates failures and deviations; creates reports
  • Analyses and reviews spare parts lists to ensure they are fit for purpose
  • Reviews engineering drawings for accuracy and acts to correct errors
  • Performs system walk-downs and makes changes using the change control of processes
  • Initiates and resolves client Corrective and Preventative Actions (CAPAs)
  • Provides analyses and summary reports
  • Creates and maintains job plans, maintenance and PMs
  • Provides team leadership.
  • Acts as a client representative
  • Provides CQV guidance and Engineering technical support to CQV Engineers and Specialists.
  • Provides engineering design and construction support.

Skills Required:

CQV Engineer

  • Expert understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
  • Good understanding and application of commissioning and qualification and willingness to learn
  • Good analytical, organizational, time management and problem-solving skills
  • Exceptional writing skills required to author and execute DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines
  • Be familiar with working in a construction environment and possess thorough understanding and knowledge to apply current industry guidelines and standards
  • Ability to read, interpret and correct P&IDs
  • A thorough and working knowledge 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
  • Proficient with Microsoft Word, Excel, and Project
  • Proficient with Kneat Validation Lifecycle Management Software
  • Hands-on experience working in a corporate setting as a productive and supportive member of a project team
  • Validation experience 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 and/or Kaye Digistrip
  • Engineering experience in the following areas: manufacturing process equipment. Manufacturing support systems and utility systems
  • Detail oriented with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team
  • Ability to provide self-direction and work independently or on a team
  • Project team leadership experience
  • Analytical, organizational, time management and problem-solving skills
  • Communication skills with ability to tailor messages for specific audiences such as director and above, operational and entry levels

Experience & Education Required for Associate CQV Engineer:

BS in Engineering, seven years of relevant project experience and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System/Life Science manufacture industry experience is required.  

Or

MS in Engineering, seven years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System/Life Science manufacture industry experience is required.  

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.

Job Requirements

 

Job Snapshot

Location US-NC-Raleigh
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace
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Company Overview

Applied Industrial Technologies, Inc.

Applied® (NYSE: AIT) is one of North America’s largest industrial distributors. Applied is a vital link between a full scope of suppliers' capabilities and a broad range of customers' needs. We excel in the areas of product selection and application, system-wide logistics and engineered systems.

Contact Information

US-NC-Raleigh

Snapshot
Applied Industrial Technologies, Inc.
Company:
US-NC-Raleigh
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

Expectations:

­

The CQV Engineer 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 Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.

Responsibilities/Assignments:

CQV Engineer

  • Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments
  • Authors protocols, initiates controlled documentation in support of CQV projects
  • Provides project planning, management, execution, and follow up
  • Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
  • Investigates failures and deviations; creates reports
  • Analyses and reviews spare parts lists to ensure they are fit for purpose
  • Reviews engineering drawings for accuracy and acts to correct errors
  • Performs system walk-downs and makes changes using the change control of processes
  • Initiates and resolves client Corrective and Preventative Actions (CAPAs)
  • Provides analyses and summary reports
  • Creates and maintains job plans, maintenance and PMs
  • Provides team leadership.
  • Acts as a client representative
  • Provides CQV guidance and Engineering technical support to CQV Engineers and Specialists.
  • Provides engineering design and construction support.

Skills Required:

CQV Engineer

  • Expert understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
  • Good understanding and application of commissioning and qualification and willingness to learn
  • Good analytical, organizational, time management and problem-solving skills
  • Exceptional writing skills required to author and execute DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines
  • Be familiar with working in a construction environment and possess thorough understanding and knowledge to apply current industry guidelines and standards
  • Ability to read, interpret and correct P&IDs
  • A thorough and working knowledge 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
  • Proficient with Microsoft Word, Excel, and Project
  • Proficient with Kneat Validation Lifecycle Management Software
  • Hands-on experience working in a corporate setting as a productive and supportive member of a project team
  • Validation experience 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 and/or Kaye Digistrip
  • Engineering experience in the following areas: manufacturing process equipment. Manufacturing support systems and utility systems
  • Detail oriented with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team
  • Ability to provide self-direction and work independently or on a team
  • Project team leadership experience
  • Analytical, organizational, time management and problem-solving skills
  • Communication skills with ability to tailor messages for specific audiences such as director and above, operational and entry levels

Experience & Education Required for Associate CQV Engineer:

BS in Engineering, seven years of relevant project experience and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System/Life Science manufacture industry experience is required.  

Or

MS in Engineering, seven years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System/Life Science manufacture industry experience is required.  

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.

Job Requirements

 
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