Senior Validation Engineer - Madison, United States - Automated Systems

Automated Systems Madison, United States

3 weeks ago

Description

Contract, 6 months | Automated Systems, Inc. | United States
Posted On 04/26/2024
Job Information

Biotechnology
State/Province

Wisconsin

City

Madison

53711
Job Description

Senior Validation Engineer

6+ month contract role - On-Site

sponsorship is not available for this role now or in the future

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.

Project Management - 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.

Requirements

Mandatory Qualifications

BS in Mechanical Engineering, or related Engineering discipline.

Two or more years of process validation development and execution experience in a manufacturing environment in the biotech, pharmaceutical, or IVD industry.

Strong interpersonal and communication skills.
Strong interpersonal and communication skills.
Advanced Degree (M.S. or PhD) in Engineering related discipline.

Certification as a Validation Engineer.

Two or more years of validation development and execution experience in a manufacturing environment in the Medical Device industry.

Experience implementing automated packaging equipment projects.

Experience implementing automated packaging equipment projects.

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.

Diversity is important at Promega.

We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, national origin, veteran status, disability, or any other protected class.

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