Validation Engineer

Validation Engineer

This position requires travel to and onsite work at Life Science sector (pharmaceutical, biotech, or medical device) manufacturing locations in the Northeastern United States.

To be considered for this position you must have experience with FAT, SAT, IQ and OQ documentation development and executionon Automated Systems in the pharmaceutical industry.

Position can be located in the greater Boston, MA area or the central New Jersey area.

Job Summary:

The Validation Engineer will be responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. This person will travel to top clients to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals. This role will challenge you to be a passionate and successful business family member all while expanding your technical abilities.

About Us:
Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors. Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.

How will you make an impact?

The Validation Engineer is part of the Regulatory & Compliance practice at Design Group. You will create, review, and/or execute primary validation activities for equipment, utilities, computer systems and manufacturing processes at Design Group client locations.

Responsibilities:

• FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry
• Assist in the development and execution of QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10
• Work with teams to perform investigations and troubleshoot issues related to validation
• Prepare written validation reports

Requirements:

• Candidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors
• 3+ years project experience with validation of automation, packaging, utilities and/or facilities is desired
• 3+ years project experience in the pharmaceutical or medical device environments is a plus
• Strong technical writing and oral communications
• Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

Education:

• B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

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. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

Job Type: Full-time

Pay: $80,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Vision insurance

Experience level:

• 2 years
• 3 years
• 4 years
• 5 years
• 6 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• Manufacturing facility

Education:

• Bachelor's (Required)

Experience:

• Validation Engineering (Pharma, Biotech, Medical Device): 3 years (Required)
• Consulting Industry: 1 year (Required)
• FAT, SAT, IQ and OQ documentation development and execution: 2 years (Required)
• Validation / FDA compliance documents/protocol development: 2 years (Required)

Ability to Commute:

• East Brunswick, NJ (Preferred)

Ability to Relocate:

• East Brunswick, NJ: Relocate before starting work (Required)

Willingness to travel:

• 100% (Required)

Work Location: On the road