Verista

6474 - Service Order Packaging Engineer / Project Engineer

Verista$70K — $102K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Materials Science, Industrial Design, or related fields; or equivalent experience in pharmaceutical/medical device R&D (1-3 years) may substitute.
  • Quality mindset with the ability to influence and provide project leadership.
  • Experience leading cross-functional project assignments.
  • Strong interpersonal skills in an interdisciplinary environment.
  • Broad technical knowledge in system design and product development/commercialization in packaging and devices.
  • Proven experience interacting with senior technical staff and managing suppliers.
  • Willingness to work onsite 5 days per week in Indianapolis.

Responsibilities

  • Plan and execute activities for design, characterization, and qualification of packaging components and systems.
  • Collaborate with internal and external stakeholders to facilitate project progression.
  • Design and conduct studies for packaging component specifications and filling processes.
  • Evaluate and implement new packaging technologies to meet project milestones.
  • Conduct risk assessments for components, systems, and processes.
  • Support shipping characterization studies for drug substances and products.
  • Interface with suppliers to assess component availability and relevance.

Benefits

  • High growth potential in a people-focused, fast-paced organization.
  • Competitive pay with performance-based incentives.
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances offered.
  • Health Savings Account and FSA options available.
  • 401(k) Retirement Plan with employer matching.
  • Paid Time Off with rollover options, holidays, and sick time available.
  • Tuition reimbursement program to assist with educational advancement.
  • Engaging team social activities and employee recognition programs.
Full Job Description
Overview:

The role of a Packaging Engineer in a product development setting may be focused on one or more of the following activities:
  • Developing primary and critical secondary container-closure systems (CCS) for finished / bulk drug products (parenteral / oral), and drug substances
  • Developing secondary packaging for drug products, combination products, and devices
  • Process engineering for packaging process development
  • Shipping & distribution packaging development

Service Order Packaging Engineer Responsibilities:
  • Plans and executes key activities to support the design, characterization, and qualification of packaging components, container closure systems, secondary packaging, shippers for distribution, and filling processes in accordance with PR&D and PDS quality system procedures, as applicable.
  • Partners with key stakeholders (internal and external stakeholders) to enable project progression from clinical development through commercialization.
  • Designs and leads the execution of studies to develop packaging component specifications, incoming testing methods, secondary packaging structures (carton, tray, printed materials, labels, adhesives), and/or filling profiles/processes.
  • Assists in the evaluation, development, and implementation of new packaging or filling technology solutions, to achieve project development and commercialization milestones.
  • Conducts risk assessments to evaluate components, systems, suppliers, product distribution, and/or processes.
  • Supports shipping characterization studies for both drug substances and drug products.
  • Evaluates and communicates the impact of supplier change notifications on drug substance and drug product packaging and regulatory commitments.
  • Interfaces with suppliers as needed to understand component availability and application to relevant molecule projects.
  • Supports the authoring and technical review of documentation including protocols, technical reports, control strategy, development history, and regulatory submission documentation.
  • Stays abreast of regulatory and compendial requirements for packaging components and systems.
  • Supports the technical transfer activities associated with implementing packaging systems solution across projects to enable clinical delivery and registration stability/process validation at commercial manufacturing operations (internal/external)
  • Partners with Device development, Business Unit, and Human Factor teams to drive patient-centered packaging design requirements.
  • Maintain area in a state of regulatory inspection readiness.

Requirements:
  • Bachelor of Science in Engineering, Materials Science, Industrial Design (or related fields) and/or research and development experience in the pharmaceutical / medical device industry (1-3 years) may substitute.
  • Demonstrated quality mindset, ability to influence, and provide project leadership.
  • Demonstrated ability to lead cross-functional project assignments.
  • Strong interpersonal skills and ability to work productively in an interdisciplinary environment.
  • Broad integrated technical knowledge for system and design engineering, product development, and commercialization (packaging, device, etc.).
  • Successful interaction with senior technical engineering and scientific personnel.
  • Experience working in a diverse networked technical organization with proven skills to manage suppliers and alliance partners.
  • Onsite requirement 5 days per week in Indianapolis.


For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

National (US) Range

$70,491-$102,623 USD

Benefits

Why Choose Verista?
  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Founded
2017

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