- Develop and manage the detailed project plans and timelines for the execution of validation activities ensuring compliance with Roche standards and regulatory requirements.
- Manage the qualification lifecycle of equipment and processes including design, installation, operational, performance, continuous qualification and decommissioning.
- Manage projects and serve as technical lead for the introduction of new equipment and/or products within predetermined timelines, financial forecasts and compliance requirements.
- Set the strategic, timeline and execution of complex initiatives, studies, and projects while ensuring a robust process, alignment between disciplines and functions and cost saving.
- Procure and manage external resources and materials to support validation deliverables.
- Understand and consider process knowledge to ensure equipment and process changes don't impact product quality.
- Lead complex investigations, root cause analysis, complaint trend analysis, and other related post-market surveillance activities.
- Oversight of validation change control management, deviation management, risk management for validated equipment, utilities, processes and facilities.
- Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
- Incorporate new regulations into manufacturing processes and validation program ensuring continued compliance.
- Prepare, review and approve relevant sections of regulatory submissions.
- Lead presentation of the validation program and maintenance of the validated state during periodic audits and regulatory inspections.
- Incorporate new manufacturing methods, equipment and processes to improve existing operations.
- Engage and partner with other network functions and industrial colleagues to progress process designs and qualification.
- Provide input into investigations and change control with potential impact to the site risk profile.
- Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.
- Lead and mentor validation engineers and train individuals on practices and procedures.
- BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 12 years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required.
- Experience in the pharma/biotech industry is required.
- Hands-on experience in the design, selection, installation, and validation of equipment used in aseptic processing.
- Knowledge of cGMPs or equivalent regulations. Experience working in a regulated environment, knowledge of cGMPs, and a strong understanding of the regulatory requirements specific to aseptic processing.
- Working knowledge of formulation, filling, and packaging, equipment qualification in a regulated environment is required.
- Experience in managing equipment and process related projects, including commissioning and qualification, new product introduction, technology transfers.
- Demonstrated experience in writing and reviewing SOPs and protocols for accuracy, traceability, and compliance.
- Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
- Experience working collaboratively with cross-functional teams, including development, operations, quality assurance, automation engineering, and maintenance.
- Experience in driving continuous improvement initiatives related to process, equipment, and quality systems.
- Demonstrated project management skills.
- Operational excellence and industrial engineering skills are a plus.
- Professional level written and oral communication skills.
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Principal Engineer, Process/Equipment Validation - Hillsboro, United States - Genentech
Description
The PositionAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action; we believe that good business means a better world.
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases.
To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.
Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society.We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve.
We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
Organization Overview
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products.
The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.
Job Summary:
The Principal Process/Equipment Validation Engineer will be accountable for setting the strategic direction and framework of the validation program, and leading teams in the performance of validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV)/ Process Validation (PV) and Revalidation (RV).
Responsibilities:
Qualifications / Requirements:
Link to Roche/Genentech Benefits
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us.
Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.
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