Job Description

JOB PURPOSE

The PTO Process Engineer provides technical supply support on the commercialization and manufacture of all drug products with minimal support from seniors or direct supervisor (seeking support/ escalating efficiently where needed).. He/ she supports all technical/ process activities (for example) investigations, validation and qualification processes, risk assessments and process safety management activities under his/ her responsibilities. The PTO Process Engineer also supports continuous process improvement activities to enhance site performance metrics and contributes to the global technical network to share site experiences/ knowledge and continuously expands on personal expertise. He/ she also supports the introduction of new products to the site and the transfer of drug products to other facilities. The PTO Process Engineer supports the objectives of his/her seniors and direct supervisor.

MAIN RESPONSBILITIES

Supports new product introductions to the site by supporting and/or conducting process and equipment comparisons, new raw material introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required. Authors PPQ protocols, reports and other associated documentation related to a new product introduction. Expected to have a basic knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements.

Demonstrates ability in technical writing for investigations, change request, PPQ reports and CMC sections.

Is involved in/ supports the design and execution of small/ full scale experiments using appropriate methodology and/or simulations for products/ processes to evaluate the impact of proposed changes to validated equipment/ processes. Proactively identify solutions with support from seniors or direct supervisor to address issues that arose during experiment/evaluation

Supports site and divisional capital projects and new facility start-up activities if applicable. Provide technical input to the process design to ensure its fit for purpose for routine manufacturing in collaboration/ support from colleagues. Responsible to transfer the knowledge of the project and facility to IPT colleagues

Provides technical support related to the product, equipment and manufacturing/cleaning processes in response to deviations/ product complaints/ adverse events to identify point of occurrence, root cause and corrective/ preventative actions.

Provides technical support for compliance activities such as audit and regulatory support. Collects data and documents to be presented to regulators during site inspections and for regulatory submissions.

Demonstrates an understanding of the manufacturing lifecycle of a product including technical requirements, analytical regulatory guidelines/ expectations associated with global regulatory submissions.

Supports product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g. SOPs, batchsheets, recipes), quality risk assessments, change control management/ filing support (if applicable) and validation activities such as equipment qualification, simple process validation and cleaning validation/monitoring activities. Expected to have a basic knowledge of respective compliance topics related to the above-mentioned activities and Quality by Design (QbD) and executes the requirements in support of a QbD filing where applicable.

Supports routine supply manufacture by providing ongoing technical support to the IPT, participates in Tier processes and implement opportunities for improvement utilizing Production Systems tools. Supports the activities to ensure optimum production runs, constraints and non-conformances identification and troubleshoots to resolve basic issues in production systems.

Proactively monitors the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. Participates in

Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance.

In addition, participates in Continued Process Verification and Annual Product review activities as part of product lifecycle management.

Demonstrates basic knowledge of statistical and risk analysis tools to identify action required to ensure product robustness across various types of manufacturing equipment and processes.

Demonstrates understanding of product CPP, CQA, Cpk and (where applicable) sterile boundary of the current validated processes. Familiar with raw materials and PCC (product contact components) used for the products under his/her responsibility.

Proactively monitors the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. Participates in Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance.

In addition, participates in Continued Process Verification and Annual Product review activities as part of product lifecycle management.

Demonstrates basic knowledge of statistical and risk analysis tools to identify action required to ensure product robustness across various types of manufacturing equipment and processes.

Demonstrates understanding of product CPP, CQA, Cpk and (where applicable) sterile boundary of the current validated processes. Familiar with raw materials and PCC (product contact components) used for the products under his/her responsibility.

Participates in the collaboration and sharing of best practices across the global network.

Complies with all divisional and site-specific policies, guidelines and procedures.

Demonstrates and promotes Environmental, Health & Safety (EHS) leadership behaviors, ensuring that all activities are carried out in accordance with EHS requirements. Actively participates in GEMBA safety walks. Participates in process hazards analyses (PHA) and applicable

Process Safety Management (PSM) activities related to new/inline products.

Where applicable, develops SOPs, gap analyses and procedures for

Quality/EHS subsystems/ topics in compliance with regulatory requirements, divisional and corporate policies and guidelines.

Demonstrates leadership behaviors in alignment with leadership standards (Individual Contributor). Practices Inclusion as the How.

Engages in personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mapping.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Qualification:

Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry, Biological sciences or Pharmaceutical Sciences

Experience:

Pharmaceutical experience preferred, fresh graduates are encouraged to apply

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:

Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Accountability, Applied Engineering, Biological Engineering, Chemical Engineering, Data Analysis, Detail-Oriented, Engineering Standards, Equipment Maintenance, Estimation and Planning, Field Failure Analysis, Management Process, Manufacturing Processes, Manufacturing Quality Control, Pharmaceutical Sciences, Process Design, Process Improvements, Product Formulation, Teamwork, University Education

Preferred Skills:

Job Posting End Date:

10/20/2025

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