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Full-time
bachelor degree
Posted 33d ago
~40 hrs/week
Responsibilities
The Process Validation Engineer supports the development, execution, and lifecycle management of process validation activities for pharmaceutical and sterile injectable products. Key duties include authoring PPQ protocols, monitoring critical process parameters (CPPs), and supporting technology transfer and continuous process verification.
Requirements
Candidates must have a Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field with over 5 years of experience in pharmaceutical or sterile injectable manufacturing. Proficiency in cGMP regulations, FDA/ICH guidelines, and statistical analysis tools like JMP or Minitab is required.
Full job description
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Process Validation Engineer is a member of the Manufacturing Science & Technology (MS&T) organization responsible for supporting the development, execution, and lifecycle management of process validation activities for pharmaceutical and sterile injectable products. The role focuses on Process Performance Qualification (PPQ), Continued Process Verification (CPV), technology transfer support, process monitoring, and validation documentation. The engineer collaborates with Manufacturing, Quality, Process Development, Engineering, and Regulatory Affairs to ensure manufacturing processes are robust, compliant, and capable of consistently producing high-quality products.
Role Responsibilities:
Process Validation & PPQ
Author and execute Process Performance Qualification (PPQ) protocols, reports, sampling plans, and validation documentation.
Support development and implementation of process validation strategies in accordance with FDA, EMA, and ICH guidelines.
Coordinate validation activities with Manufacturing, Quality Control, Quality Assurance, and Engineering teams.
Analyze validation data and perform statistical evaluations to assess process capability and performance.
Support process risk assessments using tools such as FMEA and process mapping.
Ensure validation activities are completed in compliance with cGMP requirements and site procedures.
Continued Process Verification (CPV)
Monitor and trend critical process parameters (CPPs) and critical quality attributes (CQAs).
Generate CPV reports and evaluate process performance data to identify trends and opportunities for improvement.
Support investigations related to process deviations, out-of-trend results, and process excursions.
Participate in implementation and verification of corrective and preventive actions (CAPAs).
Technology Transfer Support
Support technology transfer activities for new products, process improvements, and manufacturing scale-up projects.
Assist in developing process descriptions, manufacturing instructions, and transfer documentation.
Participate in process fit-gap assessments and risk evaluations.
Support equipment qualification, facility readiness assessments, and process characterization activities.
Process Monitoring & Continuous Improvement
Utilize statistical tools and process data to identify process variability and opportunities for optimization.
Support process robustness initiatives and operational excellence projects.
Assist in development of process control strategies and process capability assessments.
Participate in root cause investigations and implementation of process improvements.
Documentation & Compliance
Prepare, review, and maintain validation protocols, reports, technical assessments, and supporting documentation.
Ensure documentation is accurate, complete, and inspection-ready.
Support change control assessments and validation impact evaluations.
Participate in internal audits, customer audits, and regulatory inspections as a subject matter expert for assigned validation activities.
Cross-Functional Collaboration
Work closely with Manufacturing, Quality, Process Development, Regulatory Affairs, and Engineering teams.
Provide technical support for manufacturing operations and process troubleshooting.
Assist with regulatory submissions and responses related to process validation and manufacturing process performance.
Present validation findings and recommendations to cross-functional teams and site leadership.
Basic Qualifications
Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or related technical field.
5+ years of experience in pharmaceutical, biopharmaceutical, or sterile injectable manufacturing.
Experience with process validation, PPQ execution, CPV, technology transfer, or manufacturing support activities.
Working knowledge of cGMP regulations, FDA guidance, and ICH validation principles.
Strong technical writing, analytical, and problem-solving skills.
Experience with statistical analysis tools such as JMP, Minitab, or equivalent software.
Preferred Qualifications:
Experience in sterile injectable, aseptic manufacturing, biologics, or combination products.
Familiarity with visual inspection, assembly, labeling, serialization, and packaging operations preferred.
Knowledge of process characterization, process capability analysis, and statistical process control.
Experience supporting technology transfer activities.
Experience supporting regulatory inspections and customer audits.
Familiarity with equipment qualification and computerized
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
Related keywords
Process Performance QualificationContinued Process VerificationSterile InjectablesFDA GuidelinesEMA GuidelinesICH ValidationCritical Process ParametersCritical Quality AttributesFMEAcGMPCAPATechnology TransferJMPMinitabProcess Capability AnalysisStatistical Process Control
Kindeva is a purpose-fueled, people-centric CDMO dedicated to advancing your project, your ambitions, and our industry. With a legacy of innovation and deep expertise in complex drug development, we serve as a trusted partner to pharmaceutical companies worldwide.
For us, fast-tracking healthier tomorrows starts with industry-leading finished-dose expertise. From early-stage formulation to full-scale commercial production, we optimize every step to help bring life-changing therapies to patients faster.
Built on a rich heritage of regulatory diligence and blockbuster devices, our expertise sharpens, optimizes, and maximizes your project—combining best-in-class facilities with specialist capabilities in injectable, inhalation, and dermal delivery, to ensure exceptional-by-design solutions throughout.
Strategically minded and dedicated to your lasting legacy, we provide value beyond manufacturing, turning your long-term possibilities into achievable milestones.
Because every patient deserves tomorrow.
For more information about how we can transform tomorrows together, please visit www.kindevadd.com.
Offices: 11200 Hudson Rd, Woodbury, Minnesota 55129, US · St. Paul, Minnesota 55144, US · Loughbourgh, Leicestershire LE11 5RB, GB · Northridge, CA 91324, US
InhalationMicroneedlesContract Development Manufacturing OrganizationMDIPulmonaryNasalDermalInjectablesand CDMOManufacturing
Kindeva is a purpose-fueled, people-centric CDMO dedicated to advancing your project, your ambitions, and our industry. With a legacy of innovation and deep expertise in complex drug development, we serve as a trusted partner to pharmaceutical companies worldwide.
For us, fast-tracking healthier tomorrows starts with industry-leading finished-dose expertise. From early-stage formulation to full-scale commercial production, we optimize every step to help bring life-changing therapies to patients faster.
Built on a rich heritage of regulatory diligence and blockbuster devices, our expertise sharpens, optimizes, and maximizes your project—combining best-in-class facilities with specialist capabilities in injectable, inhalation, and dermal delivery, to ensure exceptional-by-design solutions throughout.
Strategically minded and dedicated to your lasting legacy, we provide value beyond manufacturing, turning your long-term possibilities into achievable milestones.
Because every patient deserves tomorrow.
For more information about how we can transform tomorrows together, please visit www.kindevadd.com.
Offices: 11200 Hudson Rd, Woodbury, Minnesota 55129, US · St. Paul, Minnesota 55144, US · Loughbourgh, Leicestershire LE11 5RB, GB · Northridge, CA 91324, US
InhalationMicroneedlesContract Development Manufacturing OrganizationMDIPulmonaryNasalDermalInjectablesand CDMOManufacturing