The PTO Lead Process Engineer leads new product introductions and the transfer of drug products to other facilities of moderate/high complexity independently and is a coach for his/her colleagues on the commercialization and manufacture of all drug products. He/ she typically will assume the responsibilities of a technical product steward and leads/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 Lead Process Engineer also leads/supports continuous process improvement activities to enhance site performance metrics and provides advanced/expert knowledge to the site and across our global technical network (while leveraging on other site experiences / knowledge) and continuously expands on personal expertise. He/ she will also provide technical supply support independently. The PTO Lead Process Engineer is expected to possess advanced/expert knowledge of at least one process/platform technology and supports the objectives of his/her seniors and the direct supervisor.
WHAT YOU WILL DO
MAIN RESPONSBILITIES
- Leads new product introductions to the site by conducting process and equipment comparisons, new raw materials introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required. Identifies and implements strategies for PPQ matrixing, novel technologies and new products etc. Authors PPQ protocols, reports and other associated documentation related to a new product introduction. Expected to have an advanced knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. Anticipates and remediates quality issues and challenges from the technology transfer process. Demonstrates advanced knowledge in technical writing for investigations, change request, PPQ reports and CMC sections.
- Leads and/or 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 independently to address issues that arose during experiment/ evaluation
- Leads/ provides technical guidance in support of site and divisional capital projects and new facility start-up activities. Ensures that the process design is well thought-out and robust for routine manufacturing. Provide technical input independently to the process design to ensure its fit for purpose for routine manufacturing. Responsible to transfer the knowledge of the project and facility to IPT colleagues.
- Provides technical expertise 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. Demonstrates ability to lead and resolve complex technical issues and investigations and resolve with minimal supervision.
- Provides technical expertise for compliance activities such as audit and regulatory support. Acts as primary regulatory representative with business partners and regulatory agencies for moderately complex products/ programs/ issues.
- Manages product portfolio activities and is expected to manage a project team for activities associated with the product portfolio. 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 an advanced knowledge of respective compliance topics related to the above-mentioned activities. Demonstrates good project management skills (e.g. define core team and activities, project scheduling, stakeholder management and issues escalation etc), and demonstrates the ability to manage/ influence the project team.
- Supports routine supply manufacture by providing on going technical support to the IPT, participates in Tier processes and implements opportunities for improvement utilizing MPS (Our Production Systems) tools. Ensures optimum production runs, identifies constraints and non-conformances and troubleshoots to resolve complex issues in production systems. In addition, conceptualizes process designs to troubleshoot and resolve complex operational or manufacturing issues and recommend enhancements to improve production runs and enable the continuously improvement of the product cost structure.
- Manages and performs the proactive monitoring of the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. This could involve leading/participating in Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance. Undertakes responsibilities as an active site product steward and is a member of the Value Chain Technical Team where applicable.
- In addition, leads Continued Process Verification and participates in Annual Product review activities as part of product lifecycle management. Applies moderately complex statistical and risk analysis tools to evaluate actions required to ensure product robustness across applicable manufacturing equipment and processes.
- Demonstrates advanced understanding of product CPP, CQA, Cpk and sterile boundary of the current validated processes. Has good knowledge of the raw materials and PCC (product contact components) used for the products under his/her responsibility.
- Actively participates and shows commitment to collaboration and sharing of best practices across the global S&T network. Typically possesses advanced and/or expert knowledge in at least one platform technology/ process.
- 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. Leads/ participates 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. Typically possesses advanced and/or expert knowledge in at least one compliance topic.
- Demonstrates leadership behaviors in alignment with our leadership standards (Individual Contributor). Practices Inclusion as the How.
- Leads personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mapping.
- Any other duties as assigned by the Supervisor.
WHAT YOU MUST HAVE
Qualification:
- Bachelor's degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences
Experience:
- Minimum 5 to 10 years technical experience in related pharmaceutical manufacturing industry.
- Demonstrated capability to successfully lead teams in complex projects.
- Expert knowledge of core technology/unit operations relevant to active pharmaceutical ingredient, Biotech and/or Non-Sterile manufacturing.
Leadership, Professional and Functional Competencies
- Demonstrate leadership skills in alignment with our Leadership Standards, focusing on build talent, fostering collaboration and drive results.
- Effective communication skills, both oral and written. Ability to work effectively on cross- functional teams as a leader or a core member.
- Strong Leadership capabilities, with desire for active people development in the organization.
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
