Key Responsibilities
Validation Documentation & Execution
Author, review, and approve validation protocols, reports, and associated documentation including acceptance criteria development
Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements
Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements
Project & Program Management
Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report review
Manage external vendors and contractors performing qualification activities
Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects
Develop and maintain validation project timelines and deliverables
Compliance & Change Control
Review proposed changes to validated systems and provide impact assessments
Identify validation requirements necessary to maintain systems in a validated state following change implementation
Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant
Support equipment and building monitoring systems compliance and updates
Technical Expertise
Serve as Subject Matter Expert (SME) in one or more of the following disciplines:
Process Mapping
Quality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation)
Equipment qualification (autoclaves, controlled temperature units, filling equipment)
Cleaning validation Aseptic process simulation (media fills)
Computer system validation (CSV)
Process validation Utility qualification (WFI, purified water, clean steam, HVAC)
Environmental monitoring systems
Provide technical guidance and troubleshooting support for equipment and system failures
Deliver training on validation program elements to junior validation personnel
Quality Systems Support
Author and support equipment and process-related deviation investigations and CAPA activities
Perform and support risk assessments (FMEA, etc.) and data integrity assessments
Support internal audits and regulatory agency inspections
Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures
Qualifications
Education
Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
Master's degree (MS/MSc) preferred
Experience
Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment
Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment
Demonstrated expertise as a Subject Matter Expert (SME) in one or more validation disciplines
Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment
Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
Capital project experience including equipment design, selection, and commissioning preferred
Skills & Competencies
Strong technical writing skills with ability to author clear, compliant documentation
Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)
Understanding of GDP requirements and ALCOA+ data integrity principles
Excellent communication and interpersonal skills with ability to interface across all organizational levels
Strong project management and organizational skills
Ability to work independently with minimal supervision while also functioning effectively in a team environment
Self-motivated with demonstrated initiative and problem-solving abilities
Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus
Working Conditions
On-site presence required; may involve work in manufacturing, laboratory, and utility areas
Ability to gown into cleanroom environments as required
Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules#LI-TH1
er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.
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
