Simtra BioPharma Solutions
Senior Packaging Technician- 1st Shift
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Overview
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. ________________________________________________________________________________________________ The role
The Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development, equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support. This position reports to the Manager, Packaging Validation.
The responsibilities: Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment Develops and executes Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc. Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS) Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders. Formulates and recommends validation procedures and technical work in accordance with project and business objectives Participates in client and regulatory audits Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications Acts as Change Control Management (CCM) Owner, Non-Conformance and OCR (Out of Control Report) author Identifies and implements changes to Automated Inspection Machines Reviews and approves Packaging Technical Services documents
Desired qualifications: Bachelor’s degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required. In-depth process knowledge of related manufacturing equipment and process preferred Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams. Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.) Manages time effectively and independently within assigned responsibilities Ability to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelines Operates as a self-starter having the ability to complete tasks with minimal direction from manager Exhibits a sense of urgency to meet timelines and key milestones Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones Physical/Safety Requirements
Must be able to lift up to 25 lbs. Duties may require overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment is required Position requires sitting/standing for long hours, but may involve walking or standing for periods of time Must wear appropriate Personal Protective Equipment as applicable Must fully understand company safety rules and regulations In return, you’ll be eligible for
Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental 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 Additional Benefits Voluntary Insurance Benefits Vision Coverage Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union Note:
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. Disability Status Self-Identification and related information are voluntary and used for EEO reporting. See Voluntary Self-Identification sections for details. Voluntary Self-Identification 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. 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. 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, for example
a list of common disabilities is provided in the original text. 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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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. ________________________________________________________________________________________________ The role
The Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development, equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support. This position reports to the Manager, Packaging Validation.
The responsibilities: Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment Develops and executes Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc. Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS) Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders. Formulates and recommends validation procedures and technical work in accordance with project and business objectives Participates in client and regulatory audits Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications Acts as Change Control Management (CCM) Owner, Non-Conformance and OCR (Out of Control Report) author Identifies and implements changes to Automated Inspection Machines Reviews and approves Packaging Technical Services documents
Desired qualifications: Bachelor’s degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required. In-depth process knowledge of related manufacturing equipment and process preferred Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams. Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.) Manages time effectively and independently within assigned responsibilities Ability to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelines Operates as a self-starter having the ability to complete tasks with minimal direction from manager Exhibits a sense of urgency to meet timelines and key milestones Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones Physical/Safety Requirements
Must be able to lift up to 25 lbs. Duties may require overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment is required Position requires sitting/standing for long hours, but may involve walking or standing for periods of time Must wear appropriate Personal Protective Equipment as applicable Must fully understand company safety rules and regulations In return, you’ll be eligible for
Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental 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 Additional Benefits Voluntary Insurance Benefits Vision Coverage Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union Note:
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. Disability Status Self-Identification and related information are voluntary and used for EEO reporting. See Voluntary Self-Identification sections for details. Voluntary Self-Identification 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. 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. 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, for example
a list of common disabilities is provided in the original text. 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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