The Manager, Quality Engineering a full-time position located at the AGC Biologics facility located in Bothell, Washington. The primary focus for this role is to lead the Quality Assurance Engineering Operations team to support Validation and Engineering teams with quality oversight of execution of validation and qualification activities for site facility, utilities, and manufacturing and testing equipment. This position is responsible for performing Gap Analysis, CAPA, and Change Control. This position also supports IQ/OQ and/or PQ activities, re-qualification, enrollment, or commissioning for utilities and equipment used in GMP work environment. The position has the ability to grow and mature the current quality assurance engineering operations procedures, management, and tools and develop team and staff members.
- Responsible for leading a project and oversight of validation deliverables among multiple groups in the organization. Ensures clear communication and alignment between cross-functional
- Authors, executes and/or reviews validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations.
- Schedules and executes validations per standard operating procedures and regulatory guidelines.
- Lead assigned validation related investigations
- Provide quality oversight on site validation activities and capital projects
- Champion and lead continuous improvement efforts on every aspect of validation
- Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Foster cross-departmental relationships (QC, Materials Management, Manufacturing, QA and site leadership) by representing Validation at team meetings.
- Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
- Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.
- Use Good Engineering practice on assigned duties.
- Lead and drive accountability of a diversified team of Quality Engineer professionals responsible for cGMP review and approval of GMP deviations, investigations, and CAPAs in regards to facilities, utilities, and equipment.
- Make and execute operational decisions with a strategic perspective
- Support operations in continuous improvement initiatives by providing direction on requirements for proposed changes
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
- Demonstrate effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives
- Provide support for internal and regulatory audits and inspections, as required
- Other duties as may be required, according to the changing needs of the business
KNOWLEDGE, SKILLS & ABILITIES:
- Must have working knowledge of cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, Data Integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), industry good practices for Installation Qualification/Operational Qualification/Performance Qualification and Standard Operating Procedures
- Must be self-motivated, organized, and proactive.
- Technical experience with validation of facility, utility and equipment
- Proven experience successfully managing multiple projects simultaneously.
- Demonstrated ability to build effective working relationships across departments (MSAT, Process Development, Project Management, and Business Development) to support new processes and products.
- Demonstrated experience leading troubleshooting efforts.
- Strong communication skills necessary to interact with internal stakeholders.
- Strong presentation skills.
- BS in Engineering, Biology or related field required
- Minimum of 10 years of experience in the biotechnology or pharma industry with experience in biologics
- Minimum of 4 years of experience in managing staff
- Strong experience and thorough understanding of Quality Systems and risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.
- Must have experience writing, reviewing, approving and managing GMP documentation.
- Equivalent education and experience may substitute for stated requirements.
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.