6474 - Service Order Packaging Engineer / Project Engineer

Verista•Indianapolis, IN

4d•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise. 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.

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.

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.