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Process Engineer - Remote

In Pennsylvania / United States

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Process Engineer - Remote   

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JOB TITLE:

Process Engineer - Remote

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Lansdale Pennsylvania / United States

JOB DESCRIPTION:

Job Title Process Engineer

Location Lansdale, Pennsylvania 19446

Duration 10 Months

Qualifications:

This position is FT remote.

Three main skills: Competency, Technologies, Manage investigations on those technologies 9how to do it), Quality

Soft Skills: Excellent Interaction with people, Build good relationships with people, Communication, Manager is not looking for someone with API, Needs more Pharma Background.

What line of business might someone done in the past; Pharma technology, Commercial

The departments function: Scientific Manufacturing process, Technical transfer, Quality, A person on this team should be collaborative, have leadership skills.

There are eight team members to team with Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate.

With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation Reporting into a Director Pharmaceutical Technical Operations External Manufacturing , the Associate Director Engineering will be responsible for leading the technical interface with strategic external partners at the Focus Factory level.

This leader will be a member of External Manufacturing Technology group within Pharma Technical Operations - External organization.

This role acts as the technical interface between the company and Contract Manufacturing Organizations (CMO) Position Description: The incumbent will provide technical leadership and oversight in the areas of technology transfer, validation, process support, deviation resolution, change control, process optimization, project management, root-cause analysis, technical capability and due diligence assessments for assigned partners.

As such, this role is the technical point of contact for the CMO and collaborates with other core functions (Quality, Operations, Supply Chain) and specialty COEs in the Science & Technology organization where needed.

Responsibilities:

Your scope of work includes:

Technology transfers, Investigations, Process Improvements, and Change Control;

Technical support and resolution on Quality issues such as Deviations and Product Release;

Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining the external partners assigned in the region;

Responsibility for the technical aspects of Fact Finding around quality and supply investigations;

Project accountability to execute Technology Transfer and on-going process; support and highlighting the need for the leveraging of shared resources from the global Science and Technology organization;

Together with the Factory Focused Team (Ops, Quality, Tech), establishing a calibrated technical oversight approach based on the capabilities and technical competence of an external partner;

Together with the Factory Focused Team, establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with external partners in the region;

Providing technical expert consultation and review on commercial agreements;

Participating in Technical due diligence assessments;

Assuring technical site readiness for all new product introductions or transfers; Participating in Technical due diligence assessments;

Assuring technical site readiness for all new product introductions or transfers;

Participating in periodic Business and Relationship Review Meetings (as appropriate) with strategic partners

At least 8 years of hands on pharmaceutical manufacturing experience in the areas of process start up and technical transfer or demonstrated experience in pharmaceutical and packaging operations in general and solid dosage in particular, including quality systems and process technology.

Demonstrated deep technical skills in the areas of solid dosage unit operations;

In-depth understanding and proven expertise in application of quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification;

Advanced understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex tasks;

Strong analytical skills

Strong decision making skills

Strong organizational, project planning and management skills

Strong team player and collaboration skills

Strong communication and presentation skills

Strong oral and written communication skills for technical investigations Preferred Experience and Skills:

Technical skills additionally in the areas of liquid, cream/ointment, and packaging operations

Expertise in our Company's Production System including Lean Six Sigma green belt level certification with black belt preferred

Statistical data analysis with Mini-tab

Demonstrated interaction with external suppliers

Position Details

POSTED:

Jun 23, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864341522610

LOCATION:

Pennsylvania / United States

CITY:

Lansdale

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Process Engineer - Remote    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Job Title Process Engineer

Location Lansdale, Pennsylvania 19446

Duration 10 Months

Qualifications:

This position is FT remote.

Three main skills: Competency, Technologies, Manage investigations on those technologies 9how to do it), Quality

Soft Skills: Excellent Interaction with people, Build good relationships with people, Communication, Manager is not looking for someone with API, Needs more Pharma Background.

What line of business might someone done in the past; Pharma technology, Commercial

The departments function: Scientific Manufacturing process, Technical transfer, Quality, A person on this team should be collaborative, have leadership skills.

There are eight team members to team with Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate.

With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation Reporting into a Director Pharmaceutical Technical Operations External Manufacturing , the Associate Director Engineering will be responsible for leading the technical interface with strategic external partners at the Focus Factory level.

This leader will be a member of External Manufacturing Technology group within Pharma Technical Operations - External organization.

This role acts as the technical interface between the company and Contract Manufacturing Organizations (CMO) Position Description: The incumbent will provide technical leadership and oversight in the areas of technology transfer, validation, process support, deviation resolution, change control, process optimization, project management, root-cause analysis, technical capability and due diligence assessments for assigned partners.

As such, this role is the technical point of contact for the CMO and collaborates with other core functions (Quality, Operations, Supply Chain) and specialty COEs in the Science & Technology organization where needed.

Responsibilities:

Your scope of work includes:

Technology transfers, Investigations, Process Improvements, and Change Control;

Technical support and resolution on Quality issues such as Deviations and Product Release;

Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining the external partners assigned in the region;

Responsibility for the technical aspects of Fact Finding around quality and supply investigations;

Project accountability to execute Technology Transfer and on-going process; support and highlighting the need for the leveraging of shared resources from the global Science and Technology organization;

Together with the Factory Focused Team (Ops, Quality, Tech), establishing a calibrated technical oversight approach based on the capabilities and technical competence of an external partner;

Together with the Factory Focused Team, establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with external partners in the region;

Providing technical expert consultation and review on commercial agreements;

Participating in Technical due diligence assessments;

Assuring technical site readiness for all new product introductions or transfers; Participating in Technical due diligence assessments;

Assuring technical site readiness for all new product introductions or transfers;

Participating in periodic Business and Relationship Review Meetings (as appropriate) with strategic partners

At least 8 years of hands on pharmaceutical manufacturing experience in the areas of process start up and technical transfer or demonstrated experience in pharmaceutical and packaging operations in general and solid dosage in particular, including quality systems and process technology.

Demonstrated deep technical skills in the areas of solid dosage unit operations;

In-depth understanding and proven expertise in application of quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification;

Advanced understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex tasks;

Strong analytical skills

Strong decision making skills

Strong organizational, project planning and management skills

Strong team player and collaboration skills

Strong communication and presentation skills

Strong oral and written communication skills for technical investigations Preferred Experience and Skills:

Technical skills additionally in the areas of liquid, cream/ointment, and packaging operations

Expertise in our Company's Production System including Lean Six Sigma green belt level certification with black belt preferred

Statistical data analysis with Mini-tab

Demonstrated interaction with external suppliers


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