Packaging Validation Associate I - 1st Shift

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana is seeking a Packaging Validation Associate I to support all aspects of the packaging process. The role involves packaging development, equipment validation, and process documentation. The ideal candidate has a Bachelor’s degree in science or engineering, along with extensive experience in a manufacturing environment.

This position also entails managing projects, developing validation documentation, and ensuring compliance with regulatory audits as part of cross-functional teams. The role promises comprehensive benefits including medical and dental coverage and a 401(k) retirement savings plan.

Qualifications

• Minimum of 5 years manufacturing experience with 2 years of leadership required.
• Ability to review Equipment Manuals and Engineering Drawings.
• Experience with project timelines and deliverables management.

Responsibilities

• Manage projects and provide technical support for packaging operations.
• Develop and execute Validation documentation including SOPs.
• Participate in client and regulatory audits.

Skills

Process knowledge of manufacturing equipment

cGMP understanding

Microsoft Office proficiency

Leadership skills

Education

Bachelor’s degree in science or engineering

Tools

JDE

BPLM

Trackwise

Job description

This 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

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life 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
  • Short and Long‑Term Disability Insurance
  • 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

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.

Equal Employment 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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