Pharmaceutical C&Q Engineer Lead (PM) - Packaging

Job Description

Job Description

Introduction:

Visium Resources has been asked to identify qualified candidates for this Pharmaceutical C&Q Engineer Lead (PM) position focused on packaging. This position is a direct hire which is expected to be on-site in New Albany, OH. This position is for the second shift.

JOB ID: 11808

Summary:

We are seeking a highly motivated C&Q Engineer to support working on packaging equipment & device assembly equipment C&Q in our customers manufacturing facilities.

This role requires hands-on technical expertise, strong project coordination skills, and a thorough understanding of FDA and cGMP compliance requirements. The C&Q Engineer will work cross-functionally with Engineering, Quality, Manufacturing, Automation, and external vendors to ensure successful project execution and operational readiness within fast-paced life sciences environments.
Key Responsibilities:

• Lead and execute C&Q activities for pharmaceutical and biotech capital projects. 
• Prior packaging equipment C&Q experience is required.
  • device assembly C&Q experience is not required, but an asset
  • environmental rooms (i.e. incubators, cold rooms, freezers, etc..) C&Q experience is not required, but an asset
  • Kneat paperless validation experience is not required, but an asset
• Ability to write & execute C&Q documents
• Close deviations, troubleshoot, communicate with customer, vendors, etc…
• Track issues, close issues

Job Requirements:

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline. 
• 5-10+ years of C&Q engineering experience within GMP-regulated environments. 
• Strong knowledge of: 
  • cGMP regulations 
  • FDA validation requirements 
  • ISPE Baseline Guides 
  • GAMP 5 principles 
• Experience executing commissioning and qualification for: 
  • Process equipment 
  • Utilities 
  • HVAC systems 
  • Cleanrooms 
  • Automation systems 
• Experience authoring and reviewing validation lifecycle documentation. 
• Strong technical writing and documentation skills. 
• Ability to work independently within fast-paced project environments. 
• Strong client-facing communication and leadership skills. 

Additional Skills & Competencies:

• Excellent organizational and multitasking abilities 
• Strong problem-solving and analytical skills 
• Ability to manage multiple priorities and deadlines 
• Comfortable working in both office and field environments 
• Ability to travel to client sites as required

Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.

Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need. Company Description

Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company’s success is based on your success. When you work with us, you are never “just a number”. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium. Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.

Company Description

Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company’s success is based on your success. When you work with us, you are never “just a number”. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium. Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.