Job Description

Job Description

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 Pharm 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 Contract Manufacturing Organizations (CMO) and collaborates with other core functions (Quality, Operations, Supply Chain) and specialty Center of Excellences (COEs) in the Science & Technology organization where needed.

Responsibilities will include:

* Acting as the technical interface with external partners in the area of process support to aid in the resolution of production issues that could impact Supply, and also to provide guidance on process optimization.

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

Education Minimum Requirement:

* B.S. degree in Engineering, Chemistry or Pharmacy;

Required Experience and Skills:

* 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

NewCo

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R106199