Pharmaceutical C&Q Engineer Lead (PM) Packaging
Job Location:
New Albany, OH - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
Summary
- 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
- Bachelors 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.
- 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 companys 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 youre 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.
Required Experience:
IC
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