Senior Packaging Engineer

Xellia Pharmaceuticals - Cleveland, OH3.6

Full-timeEstimated: $77,000 - $110,000 a year
EducationSkills
Production

Position Summary

Responsible for the packaging processes; supporting continuous operations; and

finishing of products according to compliance requirements, customer specifications and

quality standards.

Validates processes for the complete packaging area. Provide subject matter expertise

regarding the existing and future equipment in the packaging department. Support

development of employee skills and competencies by creating and performing training

both technically and GMP.

Key Responsibilities

Lead and establish the packaging area with regards to implementing procedures.

With regards to packaging lines: Create, review and own URS, protocols etc.

Make sure that the daily production is running optimally, both in terms of output and

quality

Establish framework and support daily structure in which the packaging area can run

packaging according to defined KPIs.

Ensure that current requirements to environment, safety and health issues are met

within the production.

Be pro-active, take initiative and make decisions with a short response and involve

management when necessary.

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Carry out problem solving on the shop-floor involving relevant stakeholders.

Include team members and other relevant stakeholders in decision-making in regards to

for example planning production or deadlines impact key area milestones.

Gather and share knowledge with other Xellia sites to ensure consistency of approach

and sharing of best practices with regards to packaging related matters.

Make certain that equipment is maintained correctly according to the overall plan in line

with current pharmaceutical regulatory requirement, industry standards, government

regulations, budgetary agreements, and requirements as appropriate.

Be present on shop floor to conduct coaching of team leaders and gain process

knowledge.

Conducts daily process confirmation of to ensure processes are running as intended

and to be available for questions and input.

Help and support that all personal are trained correctly and according to standards e.g.

by carrying out training.

Guide colleagues in the importance of pro-active behaviour in regards to improving the

work environment towards zero accidents.

Report KPI status for the KPIs that you and the packaging area are responsible.

Provide Standard Operating Procedures and Work Instructions that are both

comprehendible and simple to follow by means of illustrations and pictures.

Ensure a fast and thorough follow-up on non-conformities, complaints and inspections.

Support a continuous improvement culture and mind-set within the department by

proposing optimisations.

Lead and align maintenance tasks with relevant stakeholder in other departments.

Work closely together with quality to solve quality issues as they occur and ensure

timely release of products.

Drive quick implementation of effective containments and countermeasures.

Help create a mind -set where training is not only “read-and-understand” but also

evident on the shop floor.

Ensure spare part stock on relevant equipment.

Communicate challenges and successes open and honestly to all employees in the

team.

Escalate issues standing in the way of production meeting quality and production

targets to Head of the Department in an open and honest way.

Actively engage internal and external stakeholders as required to accomplish priorities,

as stakeholder management is a critical component to succeeding.

Ensure that the economics of the business unit are aligned with the overall budgets.

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Partner with Quality to ensure processes and products are in compliance with all local,

state, and federal rules and regulations. Oversee that processes are in CGMP

compliance, and establish systems that identifies opportunities for improvement and

makes constructive suggestions for change to improve process effectiveness to

heighten quality. Develop knowledge of and understand regulatory requirements such

as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

Personnel engaged in the manufacture, processing, packing, or holding of a drug

product shall wear clean clothing appropriate for the duties they perform. Protective

apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to

protect drug products from contamination.

Requirements

Bachelor Degree required with a preference for Master’s in Engineering or in Natural

Sciences.

5-7 years in a manufacturing facility or production setting required.

Experience with high speed automated packaging equipment and systems.

GMP experience required.

Demonstrates a strong bias for action while being able to prioritize and direct activities

across a large operation.

Manage Stakeholders ensure collaboration across functions.

Physical Requirements of the Role

This position will be frequently sitting, standing, and walking. In addition, repetitive use

of hands, arm, and legs, as well as lifting and carrying up to 50 lbs. Any person shown

at any time (either by medical examination or supervisory observation) to have an

apparent illness or open lesions that may adversely affect the safety or quality of drug

products shall be excluded from direct contact with components, drug product

containers, closures, in-process materials, and drug products until the condition is

corrected or determined by competent medical personnel not to jeopardize the safety or

quality of drug products. All personnel shall be instructed to report to supervisory

personnel any health conditions that may have an adverse effect on drug products.

This job description is intended to describe the general

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here