Validation Engineer

barrywehmiller; East Brunswick Township (NJ); On-site; USD 85,000 - 135,000; Full time

Job summary

Barry-Wehmiller Design Group in New Jersey is seeking a Validation Engineer II to support validation projects for pharmaceutical equipment and related systems. You will develop and execute FAT/SAT/IQ/OQ documentation, travel to leading clients, and contribute to project design and start-up efforts.

You will bring 3+ years in validation within pharma or medical devices, strong technical writing, and the ability to collaborate with cross-functional teams.

Qualifications

• Excellent communication and interpersonal skills across all management levels, clients, and vendors.
• Minimum of 3 years of project experience validating automation, packaging, utilities and/or facilities.
• Minimum of 3 years in pharmaceutical or medical device environments.
• Experience authoring CAPAs, deviations, SOPs is a plus.
• Strong technical writing and oral communication skills.
• Proficient with Microsoft Office, Microsoft Project, and AutoCAD.

Responsibilities

• Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment; travel to top clients to support project design and start-up.
• Perform FAT, SAT, IQ and OQ documentation on automated systems in pharma.
• Develop and implement QMS procedures andICH/Q8/Q9/Q10 guidelines.
• Collaborate with teams to investigate and troubleshoot validation issues.
• Prepare written validation reports.
• Contribute to daily client and team relationships with professional delivery.

Skills

Communication

Interpersonal skills

Project management

Technical writing

Travel readiness

Education

BS in Bioengineering/ Biomedical Engineering/ Chemical Engineering

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

Validation Engineer

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a 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-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Validation Engineer II, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter expert s to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

You’ll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• 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 across the country 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.

• 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

• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

What You’ll Bring

• 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

• Minimum of 3 years project experience with validation of automation, packaging, utilities and/or facilities

• Minimum of 3 years project experience in the pharmaceutical or medical device environments

• Authoring CAPA's, deviations, SOP's 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.

• 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 II, 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.

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

Design Group