Ossium
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.
Required Qualifications
Education & 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 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 Physical Requirements
Must be able to work aseptically in controlled environments requiring special gowning (ie. over the head, face, hands, feet and body) Must be able to work in a moderately noisy environment Must be able to work around biohazardous materials and chemicals Must be able to lift, push, pull and/or carry up to 50 lbs Must be able to use hands and fingers to handle and feel objects, tools, and controls Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms In your first six months some projects you’ll work on include: Qualification of new equipment (e.g., cryotanks): Lead qualification activities to bring critical equipment online in support of expanding operations Equipment reliability improvements: Establish baselines for key equipment performance, implement monitoring and trending systems, and drive corrective actions to reduce downtime and increase consistency Maintenance strategy development: Define preventive maintenance plans for critical utilities, instruments, and manufacturing equipment. Partner with operations and facilities teams to ensure execution and documentation meet GMP expectations We offer a full slate of employee benefits including: Stock options 401(k) matching Medical, dental and vision coverage Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays Employer paid life insurance and long term disability Gym membership/recreational sports reimbursements Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, sexual orientation, gender identity, gender expression, or any other protected characteristic. Our Equal Employment Opportunity Policy Statement and theKnow Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. If reasonable accommodation is needed, please contact our People Team at careers@ossiumhealth.com or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. Principals / direct applicants only please. Recruiters, please do not contact this job poster. Equal Opportunity Employer/Veterans/Disabled Create a Job Alert Interested in building your career at Ossium Health? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Ossium Health is an onsite company, with staff required to work full-time in person at our Indianapolis facility. Can you commit to working onsite? * Select... Have you ever worked for Ossium Health as an employee, intern, or contractor? * Select... Are you legally authorized to work in the US? * Select... Will you now or in the future require visa sponsorship in order to work in the US? * Select... How did you hear about this job? LinkedIn Profile Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Ossium Health’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
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We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
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Education & 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 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 Physical Requirements
Must be able to work aseptically in controlled environments requiring special gowning (ie. over the head, face, hands, feet and body) Must be able to work in a moderately noisy environment Must be able to work around biohazardous materials and chemicals Must be able to lift, push, pull and/or carry up to 50 lbs Must be able to use hands and fingers to handle and feel objects, tools, and controls Must be able to sit or stand for long periods of time. Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms In your first six months some projects you’ll work on include: Qualification of new equipment (e.g., cryotanks): Lead qualification activities to bring critical equipment online in support of expanding operations Equipment reliability improvements: Establish baselines for key equipment performance, implement monitoring and trending systems, and drive corrective actions to reduce downtime and increase consistency Maintenance strategy development: Define preventive maintenance plans for critical utilities, instruments, and manufacturing equipment. Partner with operations and facilities teams to ensure execution and documentation meet GMP expectations We offer a full slate of employee benefits including: Stock options 401(k) matching Medical, dental and vision coverage Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays Employer paid life insurance and long term disability Gym membership/recreational sports reimbursements Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, sexual orientation, gender identity, gender expression, or any other protected characteristic. Our Equal Employment Opportunity Policy Statement and theKnow Your Rights: Workplace Discrimination is Illegal Poster reaffirm this commitment. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. If reasonable accommodation is needed, please contact our People Team at careers@ossiumhealth.com or 650-285-0603. Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. Principals / direct applicants only please. Recruiters, please do not contact this job poster. Equal Opportunity Employer/Veterans/Disabled Create a Job Alert Interested in building your career at Ossium Health? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Ossium Health is an onsite company, with staff required to work full-time in person at our Indianapolis facility. Can you commit to working onsite? * Select... Have you ever worked for Ossium Health as an employee, intern, or contractor? * Select... Are you legally authorized to work in the US? * Select... Will you now or in the future require visa sponsorship in order to work in the US? * Select... How did you hear about this job? LinkedIn Profile Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Ossium Health’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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