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 Commerc…
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Full-time
bachelor degree
Professional Development Resources, Mentorships, First-Year Experience Program, Individual Development Plans, Career Path Resources
Posted 24d ago
~40 hrs/week
Responsibilities
Develop and execute validation and FDA compliance protocols for pharmaceutical equipment, facilities, and processes. Support capital projects by performing risk assessments, troubleshooting issues, and preparing validation reports for clients.
Requirements
Requires a B.S. in Bioengineering, Chemical Engineering, or a related technical degree with at least 3 years of experience in pharmaceutical or medical device environments. Must be proficient in technical writing and willing to travel for project installation and client meetings.
Full 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 II
Who You’ll Work With
You will join one of our 45 offices in the US, be part of a committed team of over 1600 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 experts 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.
Establish user requirement specification 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 including: Process Equipment, Facility / Utilities, Cleaning / Process
Work with teams to perform investigations and troubleshoot issues related to validation
Analyze qualification data and recommend corrective actions
Develop & perform impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverables
Prepare validation reports
Assist in project planning, scheduling, and coordination
Provide routine communication and status updates to BW Design Group project leadership and the client. 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
Ability to work as an individual contributor as well as a team player on a large project team
Minimum of 3 years project experience in the pharmaceutical or medical device environments
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 limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
Understanding of ICH Q7 through 11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME2500
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.
#LI-TH1
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
Related keywords
FDA ComplianceICH Q7-1121 CFR Parts 21021 CFR Part 21121 CFR Part 11ISPE Baseline GuidesGAMP5ASTME2500PharmaceuticalsMedical DevicesValidation EngineeringUser Requirement SpecificationProcess EquipmentCleaning ValidationBioengineeringChemical Engineering
We’re Building A Better World.
We’re more than just a successful capital equipment and engineering solutions firm. We’re an organization fiercely committed to improving the lives of our team members across the globe. By providing meaningful work in an environment of care and compassion, we send them home fulfilled by their time with us, rather than drained by it. We understand what every human being on the planet desires: to know that who they are and what they do matter. As a business, we have a unique opportunity to let them know that they do.
Through our Truly Human Leadership culture and personal growth initiatives, we help them become their best selves. And when we bring out their best, they give their best. To their work, their team members and friends, our customers and suppliers, the people in the communities in which they work and live, and--most important of all--to their families. And before you know it, a better job has helped build a better world!
Offices: 8020 Forsyth Blvd, Saint Louis, MO 63105, US
Based on 1325 listings with disclosed salaries, most healthcare jobs in Indiana pay between $65k–$171k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in Indiana right now?
There are currently 14,328 open healthcare positions in Indiana listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Indiana?
Companies currently hiring include Indiana University Health, American Senior Communities, Franciscan Health, Ascension, CVS Health, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Indiana?
Yes — 1045 of the 14328 open healthcare positions offer remote or hybrid work (359 remote, 686 hybrid).
How do I apply for Healthcare jobs in Indiana?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.