Engineer I, Packing/Validation
105 Digital Drive Novato, CA 94949 | Contract
Bayside Solutions is seeking an Engineer I, Packing/Validation to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Engineer I, Packing/Validation
This position reports to the Sr. Manager, QA Validation CMO, and is responsible for biological and/or small-molecule process validation activities in a cGMP environment. This position will coordinate and manage process validation projects related to the implementation of material packaging and shipping processes and changes to existing processes. In addition, the position will assist users with requirements development, process acceptance criteria, and regulatory agency assessments/reports. The position will also be a key contributor assisting with change control and regulatory responses in addition to the presentation of process validation activities during regulatory agency/partner audits and inspections.
The position organizes and performs validation activities with minimal supervision. Other responsibilities of this position include: protocol generation, project management, protocol execution, final summary report generation and other duties as assigned.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Provide project management oversight for process validation activities related to biologic/small-molecule material packaging and shipping operations.
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet Agency requirements.
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
- Determine methods and procedures on new assignments with oversight from manager.
- Coordinate the activities of sub-teams.
- Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured, validation techniques/approaches and systems utilized.
- Represent Validation in multi-departmental meetings & project teams owned by QAV Shipping Process.
- Identifies and implements improvements to the QA Validation systems (department level impact).
- Generation of process validation master plans, core validation master plans and additional supporting documentation.
- Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal laboratories.
- Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- 5+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- Training in project management is preferred.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications (such as Trackwise, JMP, MS Access a plus).
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.