Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The Senior Validation Engineer will own and manage the Cleaning Validation program working with cross-functional supporting departments Engineering, Automation, Facilities, Quality Control Laboratory, Manufacturing and Quality Assurance. The cleaning validation senior validation engineer will validate cleaning process effectiveness of automated clean in place (CIP) cycles, clean out of place cycles (COP) and parts washers to effectively clean process soils and protein-based therapeutics from process equipment and parts.

Responsibilities include, but are not limited to, cleaning validation program management, cleaning validation master planning, cleaning validation assessment and determination of worst case API’s and process soils for cleaning, determining cleaning validation acceptable carry-over acceptance criteria, coordinating bench scale cleanability studies, oversight of swab sampling method recovery studies and cleaning sample analytical method validation performed by QC or outside laboratories, oversight of CIP cycle operation qualification and spray coverage testing, cross-functional investigation and closure of cleaning validation deviations and quality records including Deviation, CAPA, and Change Control associated with cleaning cycles and cleaning validation. Generation, review and approval of validation protocols, final reports, cleaning validation documents and strategies. The Senior Validation Engineer also supports customer project and QA Validation teams and evaluation of risk assessments in order to maintain continuous improvement at AGC Biologics.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

• Oversees, designs, develops, lead and manage the Cleaning Validation Program, associated protocol development, execution and reporting.
• Ensures that the Cleaning Validation Master Plan and associated program procedures and documents remain current.
• Assist process engineering to investigate CIP cycle operation failures, generate, execute and report CIP cycle OQ protocols.
• Identifies and resolves non-conformances/deviations encountered during cleaning validation execution and work with cross function team to implement corrective and preventative actions.
• Directs content of qualification protocols and reports and helps summarize results that may be viewed by clients and regulatory agencies.
• Participate in client and regulatory audits presenting the cleaning validation program, status and plan.
• Initiate, own, contribute to quality records and reports using the document control Track Wise system including change control, deviations, CAPA, SOP revision.
• Provides validation strategy in conjunction with QA and process engineering, develops and drafts cleaning process validation protocols, oversees execution of validations and reviews validation results in final reports
• Ensures that validations are documented using Good Documentation Practices and in compliance with Biologics and Regulatory Agencies, and AGC Biologics Policies and Procedures
• Collaboratively perform and continually improve validation procedures, documentation and execution activities.
• Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance
• Generate and execute cleaning verification for product change over when cleaning processes have not yet been validated.
• Manage validation contractors and projects including purchase requests and orders scope of work.
• Performs other duties as assigned by Management.

TECHNICAL & LEADERSHIP SKILLS

• Understanding of Biologics Manufacturing, Laboratory testing, and QA oversight.
• In depth knowledge of ISO and GMP/ICH/ PDA standards and guidance for equipment cleanability and CIP cycle automation.
• Ability to clearly communicate validation compliance strategy, principles of quality, and rationale through oral and written communication techniques.
• Demonstrated knowledge of scientific principles and concepts as they relate to cleaning process design and validation.
• Knowledge of CAPA, change control and deviation programs and requirements.
• Team player who is collaborative with positive attitude.
• Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
• Strong interpersonal, written/oral communication and problem-solving skills.
• Experience with regulatory inspections, internal/external audits.

EDUCATION & EXPERIENCE

• BA or BS with at least 10 years related validation, QA and/ or engineering experience or equivalent work experience or a Master degree in a scientific discipline with at least 8 years related experience; may include equivalent work experience in a cGMP manufacturing facility.
• Experience with application of validation compliance and principles of quality which drive QA strategy and oversight.
• Experience in developing project change control strategy, facilitating change control, deviations/investigations, and closure. Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
• Equivalent education and experience may substitute for stated requirements.

COMPENSATION

$110,080 - $148,610

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.