Simtra BioPharma Solutions
Manufacturing Technical Writer
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: The Manufacturing Technical Writer is responsible for performing site Non-Conformance Report (NCR) and Significant SNCRs investigations, utilizing investigative tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions and related effectiveness criteria. Personnel filling this role will be the primary investigator for the NCR and SNCRs for the entire Bloomington facility. This candidate will sit onsite at the Bloomington facility and report to the Sr. Manager, Technical Services. The responsibilities: Develop the scope and devise an approach for assigned investigations Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools Identify cross-functional team members and assemble the investigation team Confirm corrections/containment identified based on the investigation results Determine the appropriate data sources to be evaluated for the investigation and obtain the required data Investigate the root cause(s) of the issue and document the investigation results Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs) Manage multiple investigations at any given time Responsible for speaking to client auditors and regulatory authorities to explain investigations Required qualifications: BS degree required, preferably in a science or technical area or equivalent experience 2+ years technical writing experience, preferably in pharmaceutical industry Knowledge of applicable CAPA procedures, specifications, regulations and standards Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency Goal-setting, prioritize, organization, attention to detail, and time management skills Critical & creative thinking and problem-solving skills Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data Strong oral and written communication skills Ability to demonstrate strong leadership skills Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP) Ability to utilize enterprise software systems (Trackwise) Physical / safety requirements: Duties will require overtime work, including nights and weekends on occasion Ability to gown in C/D gowning area In return, you’ll be eligible for
[1] : Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance
Spouse Life Insurance Child Life Insurance
Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program
Paid Holidays Paid Time Off Paid Parental Leave and more
Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Additional Benefits
Voluntary Insurance Benefits
Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
Onsite Campus Amenities
Workout Facility Cafeteria Credit Union
[1] Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Interested in building your career at Simtra BioPharma Solutions? 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 What are your annual salary expectations? Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Do you have a BS degree (or higher) in a science and/or technical field? Select... How many years of technical writing experience do you have? How many years of technical writing experience do you have in a pharmaceutical environment? Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. 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 Simtra BioPharma Solutions’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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Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health. This role: The Manufacturing Technical Writer is responsible for performing site Non-Conformance Report (NCR) and Significant SNCRs investigations, utilizing investigative tools, identifying the root cause(s), documenting the results and processing the relevant records in the corporate Trackwise system, collaborating with impacted departments to determine appropriate corrective or preventive actions and related effectiveness criteria. Personnel filling this role will be the primary investigator for the NCR and SNCRs for the entire Bloomington facility. This candidate will sit onsite at the Bloomington facility and report to the Sr. Manager, Technical Services. The responsibilities: Develop the scope and devise an approach for assigned investigations Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools Identify cross-functional team members and assemble the investigation team Confirm corrections/containment identified based on the investigation results Determine the appropriate data sources to be evaluated for the investigation and obtain the required data Investigate the root cause(s) of the issue and document the investigation results Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle Collaborate with Action Owner/CAPA (Corrective Action and Preventive Action) Owner to develop the Action Plan/Effectiveness Plan Present in Quality Review Board (QRB) stages (initiation and closure for SNCRs) Manage multiple investigations at any given time Responsible for speaking to client auditors and regulatory authorities to explain investigations Required qualifications: BS degree required, preferably in a science or technical area or equivalent experience 2+ years technical writing experience, preferably in pharmaceutical industry Knowledge of applicable CAPA procedures, specifications, regulations and standards Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency Goal-setting, prioritize, organization, attention to detail, and time management skills Critical & creative thinking and problem-solving skills Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data Strong oral and written communication skills Ability to demonstrate strong leadership skills Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP) Ability to utilize enterprise software systems (Trackwise) Physical / safety requirements: Duties will require overtime work, including nights and weekends on occasion Ability to gown in C/D gowning area In return, you’ll be eligible for
[1] : Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance
Spouse Life Insurance Child Life Insurance
Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program
Paid Holidays Paid Time Off Paid Parental Leave and more
Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Additional Benefits
Voluntary Insurance Benefits
Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
Onsite Campus Amenities
Workout Facility Cafeteria Credit Union
[1] Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Interested in building your career at Simtra BioPharma Solutions? 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 What are your annual salary expectations? Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Do you have a BS degree (or higher) in a science and/or technical field? Select... How many years of technical writing experience do you have? How many years of technical writing experience do you have in a pharmaceutical environment? Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. 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 Simtra BioPharma Solutions’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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