Senior Specialist, Engineering M/F/D

Job Description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, Intermediates and finished products.

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.

Position Description

This position is a key member of the External Manufacturing & Network Equipment team that will be responsible for leading product/technology transfers to Contract Manufacturing Organizations (CMO) and to serve as a key technical interface liaison with our internal packaging sites in the areas of packaging equipment design/development, packaging process and controls and packaging operation.

Under general scientific and administrative direction, the engineer leverages experience gained on scientific, technical, and business issues, to lead project teams and technical staff to solve complex packaging problems. The engineer will demonstrate knowledge, skills and abilities to optimize business, technical, and compliance processes. The person in this position participates in high impact, complex cross-functional and cross-divisional teams and initiatives and provides leadership to achieve project goals. Effective collaboration with teams is essential to meet our goals/objectives. The ability to apply these skills in a fast-paced technical operations environment to resolve issues and meet customer needs in a compliant manner are at the core of this position.

Some key areas of responsibility include:

• As part of the ExM & Network Equipment team, establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner;

• Technology & Product Transfers, Qualifications, Validations, Process Improvements, and Change Control;

• Assurance of compliant packaging process execution and project management;

• Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the external packaging partners;

• Technical aspects of fact finding around quality and supply investigations, including leading root cause analyses, and developing robust preventive actions;

• Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes;

• Supporting technical due diligence assessments;

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

• Participating in periodic Business Review Meetings with external packaging partners;

• Leading complex changes of packaging images and primary, secondary, and tertiary materials;

• Qualification of changes to distribution and thermal transport/storage systems and methods for finished drug products;

• Qualification of functional aspects of container closure systems, such as Child Resistance.

Education Minimum Requirement:

• BS degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar

Required Experience and Skills:

• 7+ years of experience working in medical device, pharmaceutical or in biotech organization with hands-on experience with packaging operations support, packaging materials/components, and packaging processes.

• Knowledgeable of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques are highly desirable.

• Desirable to have prior experiences working inside a pharmaceutical packaging facility or in an External Manufacturing technical role.

• Highly proficiency in project management skills, from conception and initiation, through close-out.

• Has a mastery of packaging scientific/technical concepts and techniques, applies and furthers those concepts and techniques to execute in pursuit of resolving scientific/technical packaging issues.

• Significant experience with medical device or combination product transfer, operations support, and materials/components.

• Experience using quantitative decision tools for Risk Management and options analysis.

• Completes activities with the highest regard for all Company divisional and local site procedures for safety, quality, and regulatory compliance.

• Excellent oral and written communication skills

• Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment.

• In depth understanding and proven expertise in application of GMP’s, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification.

• General 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 task.

• Strong analytical and decision-making skills.

• Demonstrates Leadership Behaviors and Inclusive Behaviors.

Preferred Experience and Skills:

• Proven project leadership/ management and complex problem-solving skills.

• Ability to determine areas of potential risk to business success and generate gap analysis.

• Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes. Significant experience with current Good Manufacturing Practices, Pharmaceutical industry regulations, packaging equipment system life cycle and project management.

• Strong oral and written communication skills.

• Experience with key manufacturing change control compliance systems such as Veeva and/or other similar systems.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID:R324672