(Contract) CQV Engineer - Project Based

Kymanox • Wilmington, NC

6d

About The Position

Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
The (Contract) CQV Engineer will have direct experience in Commissioning, Qualification or Validation.

Requirements

• 1-3 years of experience in the Biotechnology, Pharmaceutical, and/or Medical Device industries working in one (1) or more of the following departments: Validation (preferred) Manufacturing Process Engineering, Technical Services, or Manufacturing Sciences Quality Control or Quality Assurance Process Development
• Must have experience in Life Science industry performing IOQ on automated equipment.
• Leading and executing a variety of technical projects and/or programs.
• Collaborating with highly skilled professionals.
• Commissioning, start-up, and qualification of GMP facilities, utilities, or equipment.
• Working with quality and regulatory professionals.
• Proven ability to develop validation strategy independently
• Detail-oriented
• Highly organized
• Managerial (i.e., “do things right”) or leadership (i.e., “do the right thing”) skills
• Excellent written and oral English communication skills
• Understanding of own limitations
• Fast learner
• Ability to motivate self and others
• High energy level
• Excellent problem-solving skills
• Seasoned soft skills
• Team player
• IT and technology savvy
• Understanding of FDA’s CGMPs (i.e., Quality Systems)
• Up to 50% travel is possible for support at tradeshows, conferences, and related events. A passport is required for this job.

Nice To Haves

• Experience with CSV is preferred.

Responsibilities

• Supporting executing a variety of technical projects and/or programs.
• Define, develop, and execute the validation lifecycle following GAMP5® principles – including requirement specifications and qualification protocols (e.g., URS, FRS, DDS, DR, IQ, OQ, PQ, TM) in support of Commissioning & Qualification (C&Q) activities.
• Collaborating with Engineering and Quality professionals.
• Commissioning and Qualification of GMP facilities, utilities, and equipment.
• Provide technical project leadership and contributions to CQV projects, including managing schedules, support staff, and project execution.
• Provide review and input on areas of subject matter expertise.
• Review and summarize data for presentation to quality and regulatory professionals.

What This Job Offers

• Career Level: Mid Level