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Job Description
Process Validation Engineer
AVEVA DRUG DELIVERY SYSTEMS INC - 3.7
Tamarac, FL Job Details $90,000 - $110,000 a year 22 hours ago Qualifications Statistics Process audits Document control within pharmaceutical industry Quality control statistical data analysis Statistical Process Control Drug regulation Technical writing within manufacturing Compliance audits & assessments
GMP ICH Q9
Manufacturing facility Driver's License Production validation processes Pharmaceutical company experience Quality assurance within pharmaceutical industry ICH Q10 Productivity software FDA regulations Pharmaceutical manufacturing facility experience
Full Job Description Job Summary:
This position is responsible for authoring and executing process validation protocols related to drug manufacturing processes. The role also includes compliance engineering responsibilities to ensure all validation activities and manufacturing processes meet regulatory requirements, while also supporting the compliance of all engineering activities throughout the organization. The Process Validation Engineer will work closely with the existing Cleaning Validation and Commissioning & Qualification teams while owning the process validation program. This role reports directly to [Your Title] and requires regular presence at both the Tamarac and Miramar facilities. Job Responsibilities Author, review, and execute process validation protocols and reports for drug manufacturing processes, including Process Performance Qualification (PPQ), continued process verification, and process optimization studies. Design and implement validation strategies for manufacturing processes using a risk-based approach (e.g., FMEA, ICH Q9). Collect and analyze process data during validation runs to demonstrate process consistency, robustness, and capability. Investigate process-related deviations encountered during validation activities and support implementation of corrective and preventive actions (CAPA). Collaborate with Manufacturing, Quality Assurance, and Technical Services to ensure successful execution of validation activities at both Tamarac and Miramar sites. Support technology transfers and new product introductions from a process validation perspective. Maintain the process validation program in a state of compliance, including revalidation and periodic reviews. Ensure all process validation activities and manufacturing processes comply with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR Parts 210 & 211), ICH guidelines, and other applicable standards. Support the compliance of all engineering activities throughout the organization, including review and approval of engineering change controls, deviations, CAPAs, and documentation. Provide compliance oversight and guidance for engineering projects, equipment modifications, facility changes, and system implementations. Support internal audits, FDA inspections, and customer audits by preparing validation and engineering compliance documentation, defending strategies, and addressing observations. Conduct gap analyses on process validation and engineering compliance documentation and drive remediation activities to maintain compliance. Provide technical guidance and training to cross-functional teams on process validation and compliance requirements related to engineering activities. Work closely with the dedicated Cleaning Validation team and the Commissioning & Qualification team to ensure integrated and compliant validation packages. Travel and work regularly between the Tamarac and Miramar sites as required to support validation execution and compliance activities. Job Requirements Education Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, Chemistry, or a related scientific/engineering discipline. Advanced degree (e.g., Master's or PhD) or certifications in process engineering, validation, or project management (e.g., PMP, Lean Six Sigma Black Belt) are a plus. Knowledge, Skills and Abilities Experience in both process validation and compliance roles in the pharmaceutical industry. Knowledge of aseptic processing or sterile manufacturing (if applicable to your operations). ASQ Certification (CQE, CQV) or Lean Six Sigma Green/Black Belt. Familiarity with validation software or electronic document management systems. Key Competencies Excellent technical writing and documentation skills with the ability to produce clear, compliant validation protocols and reports. Strong understanding of statistical tools for process capability analysis (CpK, PpK, control charts, etc.). Ability to work independently while coordinating with Cleaning Validation, Commissioning & Qualification, and broader Engineering teams. Proven problem-solving skills and attention to detail. Excellent communication and interpersonal skills; able to collaborate effectively across departments and sites. Proficiency in Microsoft Office and quality management systems. Ability to travel between Tamarac and Miramar sites on a regular basis (valid driver's license required). Experience Minimum 5+ years of hands-on experience in Process Validation for drug/pharmaceutical manufacturing. Strong experience authoring and executing process validation protocols (PPQ, continued process verification) in a cGMP environment. Demonstrated knowledge of
FDA 21 CFR
Parts 210/211, ICH Q8, Q9, Q10, Q11, and Process Analytical Technology (PAT). Experience supporting regulatory inspections and audits related to process validation and engineering compliance. Experience providing compliance support to engineering activities in a regulated environment is highly desirable.
