Indiana Staffing
Ossium Health Validation Engineer
Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. Ossium Health is seeking a skilled and detail-oriented Validation Engineer to lead Commissioning, Qualification, and Validation (CQV) activities at our GMP manufacturing facility. This role supports clinical production, facility upgrades, capital expansion projects, and laboratory systems. The Validation Engineer will troubleshoot complex systems and lead initiatives that enhance the performance, reliability, and regulatory compliance of equipment, facilities, and processes. This position may be upleveled to a Validation Engineer II position for qualified candidates. Key Responsibilities
Commissioning, Qualification, and Validation (CQV) Plan, execute, and document CQV activities for facilities, utilities, manufacturing equipment, and laboratory systems. Prepare, review, and approve validation protocols (DQ, IQ, OQ, PQ) in compliance with GMP standards and corporate policies. Conduct qualification testing of equipment and utilities, generate associated reports, and ensure readiness for GMP operations. Lead revalidation activities triggered by change controls, periodic reviews, or deviations. Provide validation oversight for capital expansion projects and new equipment installations. Equipment SME and Technical Owner Develop and maintain SOPs, work instructions, validation master plans, and templates to ensure proper operation of equipment and systems. Evaluate equipment and processes to identify critical parameters impacting product quality. Perform risk assessments for instruments, equipment, processes, and products. Maintain and manage master equipment and instrument inventories. Define, track, and ensure completion of preventive maintenance (PM) strategies. Perform PMs and calibrations as a backup resource. Oversee the equipment reliability program, including tracking and trending performance data. Operational Support Serve as escalation support for equipment, facility, utility, and reliability issues unresolved by operations or maintenance personnel to ensure uninterrupted production. Collaborate with cross-functional teams to support product launches, equipment qualifications, project deliverables, and continuous improvement initiatives. Train personnel on correct equipment operation and maintenance. Support internal and external audits to ensure engineering programs meet corporate and regulatory expectations. Lead investigations, root cause analyses, and corrective/preventive actions for equipment-related deviations. Manage change controls related to facilities, utilities, and equipment. Serve as the engineering representative on Ossium's Integrated Operations Team. Required Qualifications
Education and Experience Bachelor's degree or higher in Engineering. 2+ years of experience in engineering, validation, or related discipline, with at least 2 years of that experience in GMP environments within pharmaceutical, biotech, or other regulated industries. Technical Skills Strong knowledge of and hands-on experience with equipment qualification in a regulated environment. Proficient in technical writing with good documentation practices. Skilled in risk assessment, root cause analysis, and data analysis (e.g., statistical quality control). Experienced in evaluating processes, equipment, and products for sources of variation and reliability concerns. Proficient in performing and documenting deviations, investigations, and change controls. Able to influence without direct authority and adapt to evolving manufacturing needs. Strong communication skills and proven ability to collaborate across functions. Ability to quickly learn and integrate new technical subject matter. In your first six months some projects you'll work on include
Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. Ossium Health is seeking a skilled and detail-oriented Validation Engineer to lead Commissioning, Qualification, and Validation (CQV) activities at our GMP manufacturing facility. This role supports clinical production, facility upgrades, capital expansion projects, and laboratory systems. The Validation Engineer will troubleshoot complex systems and lead initiatives that enhance the performance, reliability, and regulatory compliance of equipment, facilities, and processes. This position may be upleveled to a Validation Engineer II position for qualified candidates. Key Responsibilities
Commissioning, Qualification, and Validation (CQV) Plan, execute, and document CQV activities for facilities, utilities, manufacturing equipment, and laboratory systems. Prepare, review, and approve validation protocols (DQ, IQ, OQ, PQ) in compliance with GMP standards and corporate policies. Conduct qualification testing of equipment and utilities, generate associated reports, and ensure readiness for GMP operations. Lead revalidation activities triggered by change controls, periodic reviews, or deviations. Provide validation oversight for capital expansion projects and new equipment installations. Equipment SME and Technical Owner Develop and maintain SOPs, work instructions, validation master plans, and templates to ensure proper operation of equipment and systems. Evaluate equipment and processes to identify critical parameters impacting product quality. Perform risk assessments for instruments, equipment, processes, and products. Maintain and manage master equipment and instrument inventories. Define, track, and ensure completion of preventive maintenance (PM) strategies. Perform PMs and calibrations as a backup resource. Oversee the equipment reliability program, including tracking and trending performance data. Operational Support Serve as escalation support for equipment, facility, utility, and reliability issues unresolved by operations or maintenance personnel to ensure uninterrupted production. Collaborate with cross-functional teams to support product launches, equipment qualifications, project deliverables, and continuous improvement initiatives. Train personnel on correct equipment operation and maintenance. Support internal and external audits to ensure engineering programs meet corporate and regulatory expectations. Lead investigations, root cause analyses, and corrective/preventive actions for equipment-related deviations. Manage change controls related to facilities, utilities, and equipment. Serve as the engineering representative on Ossium's Integrated Operations Team. Required Qualifications
Education and Experience Bachelor's degree or higher in Engineering. 2+ years of experience in engineering, validation, or related discipline, with at least 2 years of that experience in GMP environments within pharmaceutical, biotech, or other regulated industries. Technical Skills Strong knowledge of and hands-on experience with equipment qualification in a regulated environment. Proficient in technical writing with good documentation practices. Skilled in risk assessment, root cause analysis, and data analysis (e.g., statistical quality control). Experienced in evaluating processes, equipment, and products for sources of variation and reliability concerns. Proficient in performing and documenting deviations, investigations, and change controls. Able to influence without direct authority and adapt to evolving manufacturing needs. Strong communication skills and proven ability to collaborate across functions. Ability to quickly learn and integrate new technical subject matter. In your first six months some projects you'll work on include