Senior Process Engineer, PTO

Job Description THE OPPORTUNITY Develop strategies that align with business imperatives. Based in Singapore , the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2021, 2022, 2023). Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our Engineers support internal and external manufacturing operations to 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. WHAT YOU WILL DO The Pharm Tech Operations (PTO) Senior Process Engineer supports/leads the source of supply changes, introduction of new products to the site, and/or the transfer of drug products to other facilities either independently or with minimal support (seeking support/escalating efficiently where needed). They support/lead all technical/process activities (for example) investigations, validation and qualification processes, risk assessments, and process safety management activities under their responsibilities and could be responsible for technical product stewardship activities. They also support continuous process improvement activities to enhance site performance metrics and contribute to the global company technical network to share site experiences/knowledge and continue to expand on personal expertise. They also provide technical supply support on the commercialization and manufacture of all drug products. They support the objectives of their seniors/direct supervisor. Supports or leads (with minimal guidance) 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. Authors PPQ protocols, reports, and other associated documentation related to a new product introduction. Expected to have a working knowledge of product development, scale-up, and technical transfer, key supporting documentation, and associated regulatory requirements. Demonstrates strength in technical writing for change requests, PPQ reports, and CMC sections. Is involved in and 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 identifies solutions with support from seniors or direct supervisor to address issues that arise during experiments/evaluation. 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. Provides 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. Provides technical expertise for compliance activities such as audit and regulatory support. Monitors and addresses potential regulatory risks during various phases of the lifecycle process independently or as part of a team. Supports and manages product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g. SOPs, batch sheets, 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 working knowledge of respective compliance topics related to the above-mentioned activities. Supports routine supply manufacture by providing ongoing technical support to the IPT, participates in Tier processes, and implements opportunities for improvement utilizing company production system tools. Ensures optimum production runs, identifies constraints and non-conformances, and troubleshoots to resolve 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. This could involve leading/participating in Prospective Process Analysis (PPA), statistical analysis, and response to shifts and trends in process performance. Where applicable (under the guidance of colleagues if necessary), undertakes responsibilities as an active site product steward and is a member of the Value Chain Technical Team. In addition, participates in Continued Process Verification and 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 good understanding of product CPP, CQA and/or Cpk 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 company S&T network. Complies with all divisional and site-specific policies, guidelines, and procedures. 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 company leadership standards (Individual Contributor). 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: Bachelors, Masters, or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry, Biological sciences, or Pharmaceutical Sciences. Experience: 3 to 5 years technical experience in the pharmaceutical manufacturing industry. WHAT YOU CAN EXPECT Limitless opportunities across various areas in Manufacturing; well-structured career path. A state-of-the-art facility that delivers solutions to its customers worldwide. Highly engaging team that aims to innovate the future. Our Manufacturing & Supply Division is committed to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. 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 another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/10/2025*A job posting is effective until 11:59:59 PM 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: R315272#J-18808-Ljbffr