Process Engineer / Validation Engineer (Office Hrs 5D, cGMP, Pharma MNC)

Overview: Under general supervision, reviews specifications and determines the critical aspects of facilities, utilities, computer systems and manufacturing equipment with regard to product and process quality, writes qualification protocols for operating systems and records related test results. prepares final reports that identify the results of protocol testing and the conditions of release. Essential Job Functions: • Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. • Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment. • Assures that protocols are approved through proper channels; writes and revises validation protocols. • Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met. • Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization. • Assures that all test data is gathered and recorded in accordance with cGMP requirements. • Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria. • Writes final reports and assures that they are approved through proper channels. • Performs necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas. • Develops and communicates project timelines and status. • Complies with all GMP and safety requirements, SOP's and Company policies and procedures. • Performs related duties as assigned. • Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors • Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results • Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring Process Engineer • Coordinates all work related to Process Engineering deliverables on scheduled projects needed to meet the deadlines developed by Plant Capital Plan, New Product Introductions, and New Process Technology Developments. • Responsible for manufacturing engineering support, the development of new process technologies, and the support of new product introductions/tech transfers. • Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers and works closely with the overall Tech Transfer team. • Works closely with technical services to develop and confirm Critical and Key Process Parameters needed for Equipment and Process Validation. Develops and delivers presentations to communicate project timelines and milestone completions. • Serve as the Subject Matter Expert for equipment and processes within area of responsibility and thereby serving as the SME for investigations, design reviews, equipment/process troubleshooting , Capital Project planning , change control and other related activities for the site. • Able to work well in cross functional TEAMS, good communication and presentation skills, strong technical understanding, general automation knowledge, multi-tasking and time management • Work effectively with others from diverse backgrounds and demonstrate capability to adapt to new, different, or changing requirements. Display strong moral principles and work ethics while demonstrating initiative. Maintain a professional presence and display responsible behaviors. • Develops conceptual strategies, processing schemes, feasibility studies, PFD’s, and detailed scopes of work. • Identify and execute projects to increase safety, reduce product cost, improve product quality, improve yield, and reduce material usage. • Work on several different projects and be able to prioritize these projects. • Assists in developing control strategy and instrument process design, including emergency and shutdown procedures, instrument specification sheets, control ranges, alarm points, and automation strategy. • Authors, updates, reviews, and approves area procedures and master batch records to ensure correct content and compliance with Good Manufacturing Practices. • Designs studies, executes experiments and perform data analysis. • Writes study proposals, progress reports, development reports, and various technical memo’s. • Evaluates new technologies to improve the commercial production process. • Supports scale up activities from R&D to production. • Provides miscellaneous overhead support of facility. • Supports the assurance of a robust manufacturing process for the current registered process as experience is gained post launch. • Sets up robust process for trouble shooting. • Acts as an effective change agent. • Acts as a key player for the expansion of projects as needed to increase scale of manufacture. • Investigate deviations from standards of manufacturing process using effective root cause analysis tools. Recommending and implementing effective corrective and preventative actions. • Generating, evaluating, and implementing innovative and creative solutions. • Assist as subject matter expert for technical projects. • Capable of generating a project scope and cost plan to effectively draft a capital request. • Develops product and process knowledge in multiple process train areas. • Contributes to equipment URS development and retrofit. Participates in equipment FAT’s, SAT’s, etc. • Participate in Quality Risk Assessments and process hazards analysis activities. Job skills & knowledge: • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. • Pharmaceutical principles, practices and applications. • Principles of mathematical and statistical computations. • Interpreting software and ladder logic diagrams and flowcharts. • Interpreting electrical and mechanical blue prints and specifications including HVAC systems and. construction plans. • Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists. Basic Qualifications • Min 5 years experience working in a regulated environment • Working knowledge of Standard Operating Procedures and Protocols/Reports • Understanding of validation/qualification strategies • Knowledge of applicable quality regulations and standards • Quality or quality support experience in a regulated environment (GLP, cGMP, ISO) • 3 years quality assurance or quality control experience in cGMP pharmaceutical or drug development organization • Working knowledge of facility equipment commissioning and qualification • Working knowledge of process and cleaning validation • Working knowledge of Computer System Validation • Quality assurance or quality control experience in a cGMP pharmaceutical setting • Education: B.S. in an Engineering discipline, or Life Science degree • Required: 3-5 years quality or quality support experience in a cGMP pharmaceutical setting • Desired: 4-7 years facility, equipment, and/or cleaning validation experience in a cGMP manufacturing setting • Sound working knowledge of processing equipment used to manufacture APIs • Knowledge of clean room standards Professional Skills, Qualifications and Experience: • Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner. • Ability to utilize Good Documentation Practices during document creation and review. • Working knowledge of current regulatory guidelines and standards. • Ability to apply and incorporate pharmaceutical standards, rules and guidances. (e.g. FDA, EU, ISO, ICH, ISPE, etc.) • Comfortable in a fast-paced environment with the ability to adjust to changing priorities. • Flexible and accountable. • Detailed oriented work standards. • Office Hours 5 Days Leon Leong De Cong R1551708 Recruiter's Ref Code: #HDC EA License: 99C4599