Summary of Major Responsibilities:
The Validation Engineer will lead validation projects across all areas of validation (i.e., computer system, process, equipment, test method, and cleaning). This role will support project teams through development of validation strategy, protocol generation, validation execution, and summary report generation. This role may directly lead an individual or a small team.
Essential Duties and Responsibilities:
Leads validation projects working cross-functionally with other departments.
Authors validation plans, validation protocols, and validation summary reports for computer system, processes, equipment, test methods, and cleaning processes.
Coordinates the development of specifications (i.e., user requirements, functional requirements, and design requirements).
Coordinates validation activities by constant communication with affected departments and personnel.
Provides direction on equipment change control in accordance with appropriate procedures.
Reviews and approves validation protocols and summary reports prepared by other team members.
Participates in Process Failure Mode and Effects Analysis (FMEA) risk assessments.
Assists operators in understanding and documenting validation execution through training and being present during validation execution activities performed by other groups.
Develop Validation Associates via operator training/certification programs, acting as a certified trainer.
Drives process improvements, through the Change Request/Change Order process, or via other means.
Strong analytical and problem-solving skills to initiate correct action; ability to make rational decisions with limited information and operate independently.
Strong communication skills and ability to coordinate work with other teams.
Ability to oversee multiple projects with a strong ability to troubleshoot issues.
Strong documentation skills and attention to detail necessary in a GMP environment.
Leadership capability and ability to mentor and train others.
Ability to plan, schedule, and carry out work for successful project completion.
Ability to follow written procedures with minimal direction.
Ability to complete assignments in expected time frames and independently seek out additional work with tasks are completed ahead of time.
Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
Communicate goals clearly to employees to ensure understanding and success in achieving them.
Motivate and inspire employees to do their best work through coaching.
Maintain morale and support employee engagement initiatives.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company’s Quality Management System policies and procedures.
Regular and reliable attendance.
Ability to act with an inclusion mindset and model these behaviors for the organization.
Ability to work nights and/or weekends.
Ability to lift up to 40 pounds for approximately 10% of a typical working day.
Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
Ability to comply with any applicable personal protective equipment requirements.
Ability and means to travel between Madison locations.
Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
Qualifications:
Minimum Qualifications
Bachelor’s degree in life sciences or a field related to the essential duties of this role; or an Associate’s degree in life sciences or a field related to the essential duties of this role and 2 years of additional experience in lieu of a Bachelor’s degree.
5+ years of experience doing validation in a manufacturing environment or a field related to the essential duties of this role.
Strong proficiency to independently apply GMPs to everyday work with regards to documentation and instrument use.
Strong proficiency in Microsoft Office programs such as Excel and Word.
Authorization to work in the United States without sponsorship.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
Experience in a biotech manufacturing environment, preferably in a GMP and/or ISO 13485 environment.
Project management experience.
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EEO Disclosure:
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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