Summary:
A leading contract manufacturing Medical Device company based in Minneapolis, MN is looking for its next Senior Validation Engineer. Fresh off of expanding into new medical manufacturing markets, this company's leadership is looking to add an experienced Validation Engineer to boost their 40-person Engineering Team, with an expected start date in early March.
Qualifications:
* Bachelor's degree in Engineering or a related discipline
* Minimum of 8 years of Commissioning and Qualification (C&Q) experience in facility and equipment C&Q within the pharmaceutical, medical device, and/or biotechnology industry
* Extensive experience in utility and facility commissioning, qualification, and validation
* Thorough understanding of FDA compliance and current Good Manufacturing Practices (cGMP)
* Results-oriented individual with several years of hands-on experience, well-versed in industry concepts, practices, and procedures within a cGMP environment
* Proficiency in design documentation (URS, FS, DS, etc.), Validation (IQ, OQ, PQ, PV, RESUME, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.)
* Demonstrated ability to manage teams effectively and foster a collaborative approach
* Excellent communication skills, including verbal, written, and technical writing abilities
* Proficient in Microsoft Word, Excel, PowerPoint, Project, and adaptable to learning new computer applications quickly
Responsibilities:
* Draft technical documents associated with projects
* Prepare engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems
* Hands-on execution of commissioning and/or validation documentation in the field
* Review equipment lists, instrument lists, drawings, specifications, and submittals to ensure accuracy and completeness
* Conduct field walk downs to verify installation meets design requirements
* Identify and address deficiencies during installation and commissioning promptly
* Participate actively in mentoring and training junior engineers, and contribute to the development of internal company policies and procedures
Benefits:
* Medical, Prescription, Dental, Vision Coverage
* Employee Assistance Program
* Mental Health Resources
* Disability Coverage
* Life insurance
* Critical Illness and Accident Insurance
* Flexible Time Off (FTO) and 11 paid holiday
