1 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking an Engineer III to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
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. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- 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:
- Duties this position is in the Global Biologics Manufacturing Science and Technology group, which supports GMP manufacturing of products internally and partner sites.
- Focus on leading cross-functional projects, troubleshooting manufacturing and supplier issues, and aligning technical experts to define best practices for Single-Use Technologies (SUT) across the Global Biologics Manufacturing Network.
- Provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients.
- Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
- Lead and/or participate in global initiatives and cross-functional investigation and project teams
- Work collaboratively with Global Manufacturing Science and Technology (gMSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
- Provide leadership as the business process owner for the management of multi-site vendor initiated changes (VICs) impacting single-use technologies
- Assist supplier quality groups as a technical assessor for VICs
- Provide guidance to the global manufacturing network in order to assure consistent and timely VIC assessments are delivered
- Develop training materials and provide training sessions as needed
- Define metrics to monitor the business process performance in order to recommend future improvements
- Expand the implementation of the multi-site business process to account for material categories other than the single-use category
- Represent GBMSAT and the single-use category in meetings such as the Material Review Board (MRB) and the Single-Use Category Team (SUCat) and Supplier Quality Management (SQM) meetings as required
- Support single-use technologies at client manufacturing sites
- Define the current state of SUT conformance compared to standards
- Identify gaps and propose a remediation plan to mitigate potential compliance risks
- Align VIC management practices with internal standards and multi-site VIC processes
- Support technology transfers, audits, and regulatory filings pertaining to new and existing SUT items (e.g. antifoam bags, bioreactors, tubing sets, sampling containers, etc.)
Summary of Qualifications:
- BS/MS/PhD. in Chemical/ Biochemical Engineering or Life Sciences with at least 3-5 years of relevant industrial experience or academia (including advanced studies) after receiving Bachelor’ s degree
- Must have 3+ years' experience with Single Use Technologies and working with vendors.
- Excellent organizational and communication skills (both written and verbal)
- Experience with change control is required
- Strong problem-solving and troubleshooting skills to support polymer chemistry analysis
- Full working knowledge and experience with Single-Use equipment qualification, design and operation is required