Senior Validation Engineer

Senior Validation Engineer 

Contract: 6+ month contract role - On-site 

Location: Madison, WI

Sponsorship is not available for this role now or in the future.

Automated Systems, Inc. is looking for a Senior Validation Engineer to take on a 6+ month contract position with one of our global client’s Pharmaceutical Manufacturing Facility located in Madison, WI. In this role, the Senior Validation Engineer will be responsible for preparation and execution of process validation test procedures while being able to thrive in a challenging and fast-moving environment in an efficient manner. All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards in a manufacturing environment.

Job Summary

• Work with the Manufacturing Support and Technology (MSAT) Engineering lead and Validation Team to produce resource estimates and schedules for the validation tasks on new projects. Manage schedule activities for successful completion of validation tasks.
   
• Assist in creating Validation Master Plans for process validation projects.
   
• Responsible for preparation and execution of process validation test procedures and acceptance criteria for equipment and critical utilities validation protocols.
   
• Work directly with equipment vendors to assist them in development of process design and validation documentation, and in facilitating review/approvals.
   
• Assist Validation Lead in turnover of validated systems to process owners.
   
• Assist Project Managers in developing the validation planning portions of project plans, and in scoping the resources required for successful implementation of validation.
   
• Serve as technical resource for specification of equipment for automation projects.
   
• Proactively maintain working knowledge of current industry trends and developments in the validation field.
   
• Understands and complies with ethical, legal and regulatory requirements applicable to our business.

Mandatory Qualifications Requirements

• BS in Mechanical Engineering, or related Engineering discipline.
   
• 2+ years of process validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry.
   
• Strong interpersonal and communication skills.
   

Preferred Qualifications Requirements

• Advanced Degree (M.S. or PhD) in Engineering related discipline.
   
• Certification as a Validation Engineer.
   
• 2+ years of validation development and execution experience in a manufacturing environment in the Medical Device industry.
   
• Experience implementing automated packaging equipment projects.
   

Physical Requirements

• Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards.
   
• Ability to work in a production environment around automated equipment.
   
• Ability to work in an office environment utilizing a computer workstation.
   
• Ability to work in a lab environment with chemical, biological and packaging materials.
   
• Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.