CQV Engineer II/III

HUMACYTE GLOBAL INC•Durham, NC

1d•Onsite

About The Position

The CQV Engineer II / III will be responsible for writing, execution, and summary of commissioning, qualification, and validation protocols related to local and enterprise based computerized systems, laboratory instruments, manufacturing equipment, and facility and utility-based systems. They will support the development of validation specifications, assessments and master plans. They will prepare and complete periodic reviews and requalifications in a timely manner. All work to be conducted according to governing SOPs and cGMPs (current Good Manufacturing Practices).

Requirements

3 - 5 years of direct commissioning, qualification, validation, and/or validation experience, required.
Bachelor’s degree, required, preferably in a technical program such as Engineering, mathematics, or a scientific based field.
Ability to lift up to 20 pounds, required.
Willingness to regularly, predictably, and reliably perform required functions at work, including occasional work outside typical office hours and weekends.
Excellent communication and interpersonal skills.
Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
Excellent organizational and time management skills with ability to set own priorities in a timely manner.
High degree of flexibility and adaptability.
Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
Represents the organization in a positive and highly professional manner.

Nice To Haves

3 years of pharmaceutical / biotech experience preferred.
Specialized or strong experiences in one of the following areas: Site or enterprise based computerized systems, Laboratory instruments, Manufacturing equipment, Automation systems, Facility and utilities, Periodic Reviews, Temperature mapping equipment such as Kaye and Veriteq
Strong working knowledge of good documentation practices and FDA, EudraLex, and other regulatory agency regulations and guidance, preferred.

Responsibilities

Support activities related to commissioning, qualification, and validation of facility, utilities, laboratory instruments, manufacturing equipment, and computerized systems
Lead the creation and revision of validation assessments, including GAMP and electronic records and signatures assessments.
Familiar with Kaye AVS and Veriteq temperature mapping systems
Familiar with computerized maintenance management systems, (CMMS) like BMRAM.
Take part in the development and revision of validation specifications including URS, FRS, CS, and DS, as well as Trace Matrices.
Assist in the development of project or system specific Validation Plans.
Write, execute, and summarize commissioning, qualification, and validation protocols.
Identify and support the resolution of protocol deviations noted during protocol execution and review.
Assist in root cause analysis related to QA Deviations / Non-conformance events.
Adheres to periodic review and requalification schedule for systems per procedure and established plans.
Revise internal and external departmental procedures based on previously obtained CQV data.
Present findings and results from completed CQV deliverables in internal and external audits specific to work which was performed firsthand.
Represent the CQV team in internal meetings.
Other Duties as assigned.