Simtra BioPharma Solutions · 4 days ago
Packaging Validation Associate II - 1st Shift
Bloomington, IN
Full-time
Onsite
Mid LevelSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization specializing in sterile injectable products. The Packaging Validation Associate II will support the inspection, labeling, and packaging processes, including development and validation activities, while collaborating with cross-functional teams to ensure compliance with regulatory standards.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Manages multiple projects providing technical support for inspection/labeling/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), Site Acceptance Tests (SAT), and User Requirement Specifications (URS)
Participates in and leads 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 regulatory audits and leads Client and Vendor tours
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 Subject Mater Expert (SME), Change Control Owner, Non-Conformance and OCR (Out of Control Report) author
Identifies and implements new project onboarding, process improvements, and changes to Automated Inspection, Labeling, and Packaging Machines
Reviews and approves Packaging Technical Services documents
Qualification
Required
Bachelor's degree in a science, engineering, or technical related area is required
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: D365, BPLM, Trackwise, etc.)
Manages time effectively and independently within assigned responsibilities
Ability to prioritize multiple projects/workflows and manage time efficiently 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
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
Preferred
In-depth process knowledge of vision systems and related manufacturing equipment /process preferred
Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
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
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.
Founded in 1930
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