For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
Your role at Simtra BioPharma Solutions:
The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes. The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position reports to the Sr. Manager, Technical Services Validation.
What you'll be doing:
- Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors.
- Conduct development studies on critical equipment
- Owns and onboards new client projects, including the relevant validations on syringe lines
- Serve as line owner, conducting gap assessments and determining validation approaches when onboarding new projects
- Collaborates directly with client representatives
- Owns non-conformance investigations (NCR)
- Owns corrective and preventive actions (CAPA)
- Owns change control management tasks (CCM)
- Participates in client audits and provides rationale / justification for practices with aid from senior team member / management. Responds to audit observations and owns deliverables.
- Subject matter expert for up to 3 processes, technologies or process equipment
- Owns, plans interventions and leads syringe line media fills. Has full ownership through closure of the summary.
- Owns & drives value improvement projects (VIP) to realize savings
- Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)
What you'll bring:
- Minimum Bachelor’s degree in science related field with laboratory experience or high school diploma/GED with a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and performing studies, etc.)
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.)
- Critical thinking and problem solving skills
- High initiative and ability to deal with ambiguity
- Skills to interact professionally and collaboratively with the client representatives
- Good writing skills; technical writing & written communication. Must be good representative for Baxter with clients.
- Ability to meet Grade A and B gowning requirements.
- Ability to lift 50 lbs.
- Must be able to climb and work from ladders.
- Must be able to qualify for 20/25 corrected vision.
- Duties will require some overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires standing for long hours, but may involve walking or sitting for periods of time
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Simtra is 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.
EEO is the Law
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Pay Transparency Policy
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.