Job Description

Our client – a growing company with multiple plants in the US, needs a 2 contract Pharmaceutical Validation Engineers for cleaning, process, equipment, Utility system projects at their plant. Excellent hourly Pay rate. C2C, W2 candidates and those on OPT or TN1 visas will also be considered. No H1B transfers .

Job Posting # 2688

Job Title : Contract Validation Engineers Location: Lawrence, KS Qty : 2 needed

Comp: Total pay rate of $60 - $70 per hour (Paid weekly) inclusive of personal expenses for living/travel

Relocation: Prefer local or someone who can travel and live on their own expenses.

Duration: Initial assignment for 6 months, which could be extended based on performance and client needs

Visa Support: Will consider C2C or W2 candidates or those on OPT/TN1 visas but no H1B transfers .

Our client is a privately held company with manufacturing sites in CA + KS with around 300 people

Group Info: Be part of the medical device and pharmaceutical contract manufacturing site with around 120+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing .

This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance. This is a senior individual contributing role and will be responsible for Validation of Equipment, Process, Cleaning and Utilities systems for Sterile Aseptic Liquid Filling and Sterilizer Operations in the Pharma Industry.

Note 1: The right person with extensive relevant experience will be considered even without any degree .

Job Summary:

The Contract Validation Engineer coordinates and assists with all process and equipment changes and implementation of new systems, equipment, and product transfers.

The Engineer facilitates Process Development meetings, keeping track of validation projects and their status. The Validation Engineer researches new processes and suggests improvement for continued excellence and provides assistance on troubleshooting existing processes and equipment.

The Engineer participates in continuous improvement and Kaizen projects in support of the Quality System.

Job Description:

• Represents engineering and validation for new systems and equipment by providing technical information, writing, and review of URS documents.
• Supports engineering and validation efforts by performing FAT and SAT commissioning activities. Writes and executes protocols for qualification events.
• Apply general engineering principles to develop and implement capital projects that will reduce costs, improve operating efficiency, progress quality, and improve safety.
• Provide engineering support for new equipment upgrades and special projects.
• Develop project plans and schedules; estimate time and costs; track project progression.
• Report on project progress, limiting factors and issues, changes in project scope, develop contingency plans, and resolve issues impeding progress.
• Collaborate with production personnel to develop new projects, identify limiting factors in current projects, and create/maintain relationships.
• Assist Product Development with engineering support for new product lines.
• Comply with all company Environmental Health and Safety and Department of Health requirements.

Candidate Must Have :

• Bachelor’s degree in Engineering or related field
• Min. 2 year of Hands-on Validation experience of Utility, process, equipment or cleaning systems in the pharmaceutical industry
• Good people, communication skills to work in a team environment
• Experience with Sterile Aseptic Liquid Filling Operations in the Pharma Industry
• Ability to produce and present clear, concise, and professionally written communications and presentations.

Candidate Nice to Have:

• Master’s degree in Engineering or Technical field
• Experience in engineering, ISO execution, Quality Systems, commissioning, and qualification preferred and is used to determine job level (I-IV).
• Startup or Small company experience working in a dynamic and hands-on role.
• Contract Manufacturing experience working closely with customers and clients

Keywords: BioPharma, Pharma, Quality, Validation Equipment, Utilities, Process, cleaning, Sterile Aseptic filling, IQ, OQ, PQ, Protocols, pharmaceutical

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