Validation Engineer

Our client – a growing company with multiple plants in the US, needs a Validation Engineer at their plant expanding to manufacture pharmaceutical products. Excellent salary + Relocation + Full Benefit Package. Client will sponsor for OPT or H1B Transfer Visa.

Job Title: Validation Engineer

Location: Lawrence, KS

Compensation: Salary of $90K - $110K per year

Relocation:YES - Client offers relocation assistance – negotiated amount for reasonable moving expenses – receipts submitted for reimbursement and processed through payroll.

Benefits: Full package for medical, dental insurance, 401K, etc.

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.

The new operation expansion is for Pharma Fill Finish Seal – FFS of Sterile Aseptic liquids.

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 all the Equipment, Process and Utilities systems

Note 1: The right person with extensive relevant experience will be considered even without any degree or certification.
Note 2: The client will sponsor for H1B Transfer and OPT Visa if needed

Job Summary:

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

The Validation 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 Validation 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.
• Writes and revises procedures to support new systems or new product realization projects.
• Maintains professional and technical knowledge by attending educational workshops and reviewing professional publications.

• 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.
• Ability to work individually and within a team environment.
• Comply with all company Environmental Health and Safety and Department of Health requirements.

Facility Maintenance: Develops and Generates SOPs for equipment and system maintenance. Actively review reports and documents for compliance to requirements and troubleshoots issues. Provides system/equipment transfer of process to manufacturing/maintenance including provision for training on various systems. Ensures that all systems operate and run in a compliant manner with proper preventive maintenance schedule during validation.

Purchasing: Uses the purchasing system to procure production and maintenance supplies related to validation.

DCR System: Actively uses the DCR System to change or add new document requirements.

CIMP System: Assists Managers and leads projects for continuous improvement and Kaizen events.

NCR System: Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities. Provides reports and communication based on investigation findings.

Training: Provides training to other employees to support continued competency.

Candidate Must Have:

• Bachelor’s degree in Engineering or related field
• Min. 2 year of Hands-on Validation experience of facility, process, equipment or systems
• Good people, communication skills to work in a team environment
• 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).
• Knowledge of Sterile Aseptic Filling Operations
• Startup or Small company experience working in a dynamic and hands-on role.

• Contract Manufacturing experience working closely with customers and clients
• Higher skill set with Performance ISPE or PDA classwork/training, Developing Standards, Process Improvement, Decision Making, Troubleshooting, Quality Management, Project coordination, P&ID reading, CAD or similar engineering software, commissioning and qualification principles, ISO Systems.

Keywords: BioPharma, Pharma, Quality, Validation Equipment, Sterile Aseptic filling, IQ, OQ, PQ, Protocols, H1 B visa, OPT Visa