Position Summary Ascendia Pharmaceutical Solutions is seeking a highly motivated, hands-on Validation Engineer to support pharmaceutical manufacturing operations, equipment qualification, process development, and GMP documentation. The primary responsibility of this position is to develop, execute, and maintain equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring that manufacturing equipment, instruments, and associated systems are appropriately qualified and maintained in a state of control. In addition, the Validation Engineer will work closely with Manufacturing, Formulation Development, Quality Assurance, and Project Management to support manufacturing process implementation, develop and revise Master Batch Records (MBRs), and ensure that manufacturing instructions accurately reflect equipment capabilities, process requirements, and GMP expectations. The ideal candidate is a practical, detail-oriented engineer who is equally comfortable working on the manufacturing floor, troubleshooting equipment, executing qualification protocols, and developing technically sound GMP documentation. Key Responsibilities 1. Equipment Qualification and Validation — Primary Responsibility Develop, author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for pharmaceutical manufacturing equipment and associated systems. Prepare qualification plans, risk assessments, test scripts, acceptance criteria, deviation reports, and final qualification summary reports. Perform equipment assessments to determine qualification requirements based on intended GMP use, equipment criticality, and product quality impact. Review equipment specifications, vendor documentation, operating manuals, engineering drawings, calibration records, and supporting technical documentation. Coordinate equipment installation, commissioning, testing, qualification, and release for GMP manufacturing use. Execute qualification testing, document results, investigate discrepancies, and ensure that qualification activities meet established acceptance criteria. Support qualification and requalification of manufacturing equipment, including mixers, homogenizers, mills, filling equipment, lyophilizers, autoclaves, and other pharmaceutical processing systems. Establish and maintain equipment qualification files, validation documentation, and equipment lifecycle records. Support equipment change controls, preventive maintenance assessments, calibration requirements, and periodic qualification reviews. Work with equipment manufacturers and third-party service providers to resolve technical issues and support qualification activities. Ensure qualification documentation complies with applicable cGMP requirements, company procedures, and approved validation practices. 2. Manufacturing Process Development and Technical Support Collaborate with Formulation Development, Manufacturing, and Technical Operations to translate development processes into practical, reproducible manufacturing procedures. Support equipment selection, process setup, operating parameter definition, and manufacturing process optimization. Assist with engineering batches, demonstration batches, process scale-up, and technology transfer activities. Identify and evaluate critical process parameters (CPPs), critical quality attributes (CQAs), and equipment operating ranges, as applicable. Support process troubleshooting, root cause investigations, and implementation of corrective actions. Participate in manufacturing readiness assessments to ensure equipment, documentation, personnel, and materials are appropriately prepared for production. Assist in developing and executing process qualification and validation activities, as required. 3. Batch Record Development and GMP Documentation Author, revise, and maintain Master Batch Records (MBRs), manufacturing instructions, equipment operating procedures, and associated GMP documentation. Translate formulation development procedures, engineering batch instructions, and process parameters into clear, executable manufacturing batch records. Ensure batch records include appropriate equipment identification, material requirements, processing parameters, in-process controls, sampling requirements, calculations, and documentation instructions. Work directly with Manufacturing personnel to verify that batch record instructions are technically accurate, practical, and executable. Support batch record revisions resulting from process improvements, equipment changes, investigations, or client requirements. Assist with the preparation and revision of Standard Operating Procedures (SOPs), equipment cleaning procedures, and manufacturing work instructions. Support resolution of batch record discrepancies, manufacturing documentation issues, and process-related deviations. Ensure GMP documentation is consistent with applicable data integrity and good documentation practices. 4. Quality, Compliance, and Continuous Improvement Ensure engineering and validation activities comply with applicable FDA regulations, 21 CFR Parts 210 and 211, and relevant industry guidance, including ICH Q8, Q9, and Q10, as appropriate. Support equipment- and process-related deviations, investigations, corrective and preventive actions (CAPAs), and change controls. Participate in internal audits, client audits, and regulatory inspections by providing qualification records and technical explanations. Identify opportunities to improve equipment reliability, manufacturing efficiency, process consistency, and documentation quality. Collaborate with Quality Assurance to ensure qualification activities and associated records are reviewed and approved in accordance with established procedures. Support continuous improvement of the site's equipment qualification and validation programs. Required Qualifications Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biomedical Engineering, or a related scientific or technical discipline. Minimum of 3-5 years of relevant experience in pharmaceutical manufacturing, equipment qualification, validation, or manufacturing engineering within a GMP-regulated environment. Demonstrated experience authoring and executing IQ, OQ, and PQ protocols. Working knowledge of pharmaceutical manufacturing equipment and associated operating principles. Experience developing or revising GMP manufacturing documentation, including batch records, SOPs, and technical protocols. Knowledge of FDA cGMP regulations, qualification principles, and good documentation practices. Ability to interpret equipment specifications, engineering drawings, and technical manuals. Strong technical writing, analytical, troubleshooting, and problem-solving skills. Ability to independently manage multiple assignments and work collaboratively across technical and operational functions. Willingness to work directly in manufacturing, laboratory, and equipment areas. Preferred Qualifications Experience in a pharmaceutical Contract Development and Manufacturing Organization (CDMO). Experience supporting both sterile and non-sterile pharmaceutical manufacturing operations. Familiarity with aseptic processing equipment, lyophilization, filling systems, mixing, milling, and homogenization technologies. Experience with process scale-up, technology transfer, and engineering batch execution. Familiarity with cleaning validation, process validation, and equipment lifecycle management. Experience with validation documentation systems, electronic Quality Management Systems (eQMS), and electronic document control. Familiarity with

ASTM E2500, ISPE

Baseline Guides, and risk-based qualification methodologies. Experience supporting equipment commissioning, factory acceptance testing (FAT), and site acceptance testing (SAT).

Key Competencies Hands-On Technical Execution:

Ability to independently perform equipment qualification activities and resolve technical challenges.

Technical Documentation:

Strong ability to develop accurate, comprehensive, and practical GMP documentation.

Manufacturing Mindset:

Understanding of how equipment, processes, and documentation interact in actual production environments.

Problem Solving:

Ability to identify technical issues, investigate root causes, and implement sustainable solutions.

Cross-Functional Collaboration:

Effective working relationships with Engineering, Manufacturing, Formulation Development, Quality Assurance, and Project Management.

Ownership and Accountability:

Ability to manage assigned projects, meet commitments, and deliver technically sound work with minimal supervision. Performance Expectations Success in this position will be measured by: Timely completion of equipment qualification protocols and reports. Reduction of equipment qualification documentation gaps and outstanding qualification activities. Accuracy, completeness, and GMP compliance of validation documentation. Timely development and implementation of manufacturing batch records and operating procedures. Effective support of manufacturing readiness and new project implementation. Reduction in qualification-related deviations, documentation errors, and manufacturing execution issues. Ability to maintain equipment in a documented, qualified state throughout its operational lifecycle. Working Environment This position requires regular presence in pharmaceutical manufacturing areas, laboratories, and equipment rooms. The successful candidate must be comfortable working in GMP-controlled environments, following applicable gowning and safety procedures, and performing hands-on equipment testing and troubleshooting. The role requires flexibility to support manufacturing schedules, qualification activities, and project timelines. Equal Employment Opportunity Ascendia Pharmaceutical Solutions is an Equal Opportunity Employer committed to maintaining a professional, inclusive, and collaborative workplace. Employment decisions are based on qualifications, experience, and business requirements, consistent with applicable law.

Pay:

$100,000.00 - $125,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person