The Position
The Opportunity In this exciting role,
You will be responsible for supporting the strategic direction and framework of the entire Manufacturing Value Stream training program. You will collaborate with others to develop and assign the appropriate training content and curricula for Manufacturing operations in alignment with operational needs, internal policy and requirements, and in compliance with health authority regulations. You will support leadership in monitoring timely training completion, compliance and effectiveness. You will help ensure training gaps are appropriately resolved and actions are taken in a timely manner in response. You will be involved in delivering key training support related to product transfers and new equipment/process start-up (e.g., development of training material in collaboration with engineering, technical support and manufacturing to ensure that course material adheres to compliance requirements and will effectively build departmental capability). You will support the technical development and learning of all Manufacturing staff as it relates to process improvements, tech transfers, regulatory compliance, and new equipment/new process introduction. You will review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures and associated training. You will instruct and facilitate learning programs (both soft skills and technical as needed), which may include coordinating and developing training materials. You will actively pursue knowledge of standard methodologies and innovative technologies and processes in organization and training effectiveness to develop and improve departmental capabilities. You will support routine site regulatory inspections as a technical resource and Subject Matter Expert. You will support resolution of discrepancies particularly as it relates to operational, training, and process issues, to ensure unplanned/unexpected events are thoroughly investigated and the appropriate remediation actions are defined and pursued, to ultimately reduce the number of repeat/recurring events.
Who you are: You are someone who wants to influence your own development and can work independently, with limited supervision. You are looking for a company where you have the opportunity to pursue your own interests; where a job title is not considered the final definition of who you are, but the starting point. Experience with Single Use Technologies & Disposables in biopharmaceutical manufacturing highly preferred. Candidates MUST be able to flex and support ALL of the following Manufacturing shifts as business needs arise:
12 hr Day Shift, 6:00 am - 7:00 pm,
10 hr Day Shift, 6:00 am - 4:30 pm
Sunday - Wednesday Wednesday - Saturday
10 hr Swing Shift, 3:30 pm -2:00 am
Sunday - Wednesday Wednesday - Saturday
12 hr Night Shift, 6:00 pm -7:00 am
Behaviors, competencies, and qualities of the ideal applicant:
Ability to prioritize the needs and asks of the organization Passionate about developing people and able to adapt to their training needs Hardworking and strong interpersonal skills Experience in clean room environment under cGMP and ISO/FDA standard as well as manufacturing and assembling medical devices is strongly preferred Ability to think critically and work both tactically and strategically Strong quality mindset with attention to detail and a desire to deliver service excellence Ability to work effectively, exhibit a professional manner and establish constructive working relationships
Qualifications / Requirements:
Proficiency in the English language- reading, writing, and communication. Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job . Must re-qualify every year on all job-related training and certifications as job or qualifications require. May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. Lifting up to 25lbs may be required. The training environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment. Personal cell phones are not allowed on the clean room floor
Education:
Bachelors Degree and 8 years related experience Associate degree/Biotech Certificate and 10 years experience High school and 12 years experience
Work Experience:
Computers:
Must be computer literate, including ability to interface with computer systems and PLC-based logic. Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills and understand Google platforms.
Relocation benefits are not offered for this job posting. The expected salary range for this position based on the primary location of California is $63,000-$117,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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