Simtra BioPharma Solutions · 1 week ago
Sr. Technical Writer - Clinical Mfg.
Bloomington, IN
Full-time
Onsite
Senior Level
5+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that collaborates with pharmaceutical and biotech companies to develop sterile injectable products. The Sr. Technical Writer will be responsible for authoring technical documentation, conducting investigations, and supporting training for operators, ensuring compliance with quality standards and regulatory requirements.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Develop the scope and devise an approach for assigned CAPAs, NCRs, Batch Records and miscellaneous technical development documentation
Demonstrate ability to quantify data to draw conclusions to drive continuous improvement through document revisions and leadership utilizing cross functional teams
Provide relevant experience for training manufacturing and technical personnel both directly and indirectly
Establish a scalable framework and organization for execution of technical and quality documentation
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/authoring teams
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 clients and regulatory authorities to explain investigations
Qualification
Required
BS degree required, preferably in a science or technical area or equivalent experience
5+ years technical writing experience, preferably in pharmaceutical industry
Demonstrate direct and indirect leadership ability
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)
Benefits
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
Employee Ownership Plan
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase