Simtra BioPharma Solutions

Simtra BioPharma Solutions

Packaging Validation Associate I - 1st Shift

Bloomington, Indiana, United States

Sponsorship not specifiedDetected 12 days ago
ExcelCustomer SupportGMPLeadershipMicrosoft Office

About the role

  • 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.
  • 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.

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.
  • Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders.
  • Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications
  • Identifies and implements changes to Automated Inspection Machines
  • Reviews and approves Packaging Technical Services documents
  • Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
  • The Packaging Validation Associate I supports all aspects of the packaging process.

Requirements

  • Must be able to lift up to 25 lbs.
  • Use of hands and fingers to manipulate office equipment 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: JDE, BPLM, Trackwise, etc.)
  • Operates as a self-starter having the ability to complete tasks with minimal direction from manager
  • Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
  • Proficiency in Microsoft Word,
  • Manages time effectively and independently within assigned responsibilities
  • Ability to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelines
  • 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

Nice to have

  • 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

Benefits

  • 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.
  • It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support.
  • Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
  • Paid Parental Leave and more
  • Adoption Reimbursement Program

Company info

  • 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.
  • While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

Equal opportunity

  • 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.
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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.