Biomedical Design Engineer Jobs in Indiana (NOW HIRING)

Sr. Validation Engineer

WhoYou'llWork With

You will join one of our 45 offices in the US, bepart of a committed team ofover1500 professionals,and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed intoa rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-classprofessional consultantandsurrounded byleaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as aSr.Validation Engineer, you are joining a team that will challenge you andposition you for growth. In this role, you will work witha team ofindustry experts to helpthe world's leading companiessolve their most difficult problems. You willjoin ourRegulatory Compliance Practiceandpartner with seasoned leaders, technicalspecialists, and subject matter expertsto deliver the highest quality solutions to our clients with consistency and accuracy.

WhatYou'llDo

• You'llwork individually and in teams tosupport capitalproject CQV delivery and individual technical contribution for our clients.Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

Validation & Compliance Activities:

• Assistbasic and conceptual design phases of capital projects by working with clients and vendors on embedding compliance, testability and lifecycle thinking into early design

• Establish User Requirement Specifications for critical equipment and systems.

• Assess risk across various aspects of systems' functions and focus efforts on critical quality aspects. Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes - employing industry's most progressive Digital Validation Tools

• Prepare, execute, and manage commissioning and qualification documents for utility, facility, and process equipment

• Perform FAT, SAT, IQ, andOQdocumentation development and execution on equipment/systems.

• Conduct investigations and troubleshoot validation-related issues

• Prepare comprehensive written validation reports.
  

WhatYou'llBring

Experience Requirements:

• Sr. Validation Engineer: Minimum 7+ years demonstrated experience with design, commissioning, validation of automation, packaging drug substance (i.e., pooling, centrifugation, TFF) and/or drug product (i.e.,asepticfilling, inspection) systems/equipment, utilities(i.e.,process, equipment), and/or facilities(i.e.,HVAC,classification, contamination control)pharmaceutical or medical device environments validation

• Extensive hands-on experience with GMP-regulated environmentswithknowledgeof regulationandguidance's(i.e., CFRParts210, 211,11), Annex 1,ICHQ7/Q8/Q9,ISPEG2G)

• Experiencewith implementingrisk-basedapproaches to validationprojects

• Authoring, reviewing andapprovingValidationMaster Plans,risk assessments,deviations, andchange controls.

Technical Skills & Qualifications:

• Bachelor's degree in Engineering(Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree)

• Validation experience in automation, packaging, general drug substance and/or drug product systems/equipment, computer systems, utilities, and/or facilities

• Strong technical writing and oral communication skills

• Proficiencywith project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD)

• Experience with entire project lifecycle from concept development through startup (preferred)

Professional Attributes:

• Excellent leadership and organizational skills with ability to manage multiple responsibilities

• Outstanding communication and interpersonal skills to interact with all levels of management, clients, and vendors

• Flexibility with tasks and strong analytical capabilities

• Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events.

• Able to communicateanddeveloplong-lasting relationships withclients and project teams

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Ourmodel and entrepreneurial mindsetoffer a rewarding, challenging, andhighlyflexible path. As aSr. Validation Engineer, youwill build a meaningful and fulfilling careerwith the support of professional developmentresourcesand mentorshipsincludingourFirst Year Experience program, Individual Development Plans, and Career Pathresourcesand tools.You willbe surrounded by exceptional talentwho will supportyour development as both a world-class engineer andahighly effective leader.#LI-TH1

Feel likeyou'reon the path to becoming aSr. Validation Engineer,butyou'renot quite thereyet?We'dlove to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant.