- Process equipment installed per design.
- Start-up, Commissioning, and Qualification activities were completed on schedule.
- OSUT Manufacturing Core is fully qualified up to OQ and can be released for GMP use.
- Successful Automation SAT completion
- Completion of Operation Verification
- Successful Water Run for Process Equipment completion.
- Successful Technical Run for Process Equipment completion
- Reviews & approves validation documents and protocols.
- Participates in safety assessments/reviews.
- Ensures necessary operating procedures are in place before C&Q execution on the assigned unit operation(s)
- Ensures training materials and curriculum are developed and revised as needed.
- Performs/updates risk assessments in partnership with network and Quality counterparts.
- Coordinates and conducts start-up and troubleshooting activities.
- Execute equipment C&Q, write-up, and review using existing documentation and protocols.
- Collaborate with the client's Automation engineering team to coordinate control systems design, installation, and commissioning needed for the core processing systems.
- 15 or more years of work experience in the pharmaceutical or related industry
- 10 or more years of direct or indirect people and team management experience
- 5 or more years of work experience in a cGMP-regulated environment, preferably in biologics manufacturing
- Excellent verbal and written communication skills
- Excellent business acumen
- Ability to influence at all levels of an organization.
- Builds trustful and effective relationships.
- Thinks strategically and translates strategies into actionable plans.
- Takes responsibility, drives results, and achieves expected outcomes.
- Comfortable working in an agile and ambiguous environment
- Has demonstrated a commitment to quality.
- Bachelor's Degree required (science or engineering is preferred)
- Professional, Graduate, or higher-level degree is preferred.
-
Manufacturing Supervisor
3 weeks ago
TalentBurst Oceanside, United StatesPosition: Manufacturing Lead/Supervisor (Manufacturing Technical Specialist) · Location: Oceanside, CA (100% onsite) · Duration: 8 Months Contract (through the end of 2024, with potential extension based on the development and achievement of deliverables) · Job Description: · Th ...
-
Supervisor, Manufacturing
4 weeks ago
Gilead Sciences Oceanside, United StatesSupervisor, Manufacturing - Viral Vector · Supervisor, Manufacturing - Viral Vector · United States - California - Oceanside · Manufacturing Operations & Supply Chain · Regular · Job Description · At Gilead, we're creating a healthier world for all people. For more than 35 y ...
-
Manufacturing Production Supervisor
1 day ago
VIP Staffing San Marcos, United States Full timeWe are now hiring for a Production Supervisor for a Manufacturing company in San Marcos, TX. This position is starting ASAP Please submit your resume to this posting and call our office at · Pay: $24 base pay + $2 night shift differentialSchedule: Thursday night (Friday) 1:00am- ...
-
Manufacturing Maintenance Supervisor
3 weeks ago
K-Tube Technologies Poway, United StatesLeads the Equipment Maintenance Department and personnel for tube Manufacturing facility with 24/7 operations. Directs the repair, preventive maintenance, modification, and installation of manufacturing equipment. Ensures equipment is operating at peak efficiency to facilitate ma ...
-
Manufacturing Production Supervisor
2 weeks ago
Sumitomo Electric Interconnect Products Inc San Marcos, United States· Position at Sumitomo Electric Interconnect Products, Inc. · Job Summary · This position will lead the Manufacturing Department and/or one of its operating shifts in a supervisory capacity. This person will be responsible for the safety, organization, administration and perfo ...
-
Manufacturing Maintenance Supervisor
3 weeks ago
K-Tube Technologies Poway, United StatesLeads the Equipment Maintenance Department and personnel for tube Manufacturing facility with 24/7 operations. Directs the repair, preventive maintenance, modification, and installation of manufacturing equipment. Ensures equipment is operating at peak efficiency to facilitate ma ...
-
Manufacturing Maintenance Supervisor
3 weeks ago
K-Tube Technologies Poway, United StatesLeads the Equipment Maintenance Department and personnel for tube Manufacturing facility with 24/7 operations. Directs the repair, preventive maintenance, modification, and installation of manufacturing equipment. Ensures equipment is operating at peak efficiency to facilitate ma ...
-
Manufacturing Maintenance Supervisor
4 weeks ago
Cook Medical Poway, United StatesOverview · Leads the Equipment Maintenance Department and personnel for tube Manufacturing facility with 24/7 operations. Directs the repair, preventive maintenance, modification, and installation of manufacturing equipment. Ensures equipment is operating at peak efficiency to f ...
-
Manufacturing Engineering Supervisor
2 weeks ago
General Atomics and Affiliated Companies Poway, United StatesGeneral Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. · Under general supervision with lim ...
-
Product Development Technician
9 hours ago
JELD-WEN Oceanside, United StatesProduct Development Technician · Date: May 30, 2024 · Location: Oceanside, CA, US, 92056 · Company: Jeld-Wen Inc. · JELD-WEN is currently seeking a Product Development Technician to join our growing team. · JOB TITLE: Skilled Production/ Product Development Technician 2 ...
-
Quality Control Inspector I
1 week ago
Marquee Staffing Oceanside, United States Contract to HireExciting new opportunities in Oceanside for an innovative Medical Device Manufacturer. · Looking for Quality Control Inspector I. · 4/10 schedule 1st shift 4/10 schedule Mon-Thurs 5:30am-3:30pm with overtime on Friday's. · Job Description · SUMMARY · The Quality Control Inspector ...
-
GCSS-MC FSR/Trainer
1 week ago
Anglicotech, LLC Oceanside, United StatesWe are seeking an FSR/Trainer with immediate availability that will thrive in a challenging and rewarding process-oriented environment. This position is in the Logistics Systems Coordination Office (LSCO) at I MEF. The preferred candidate will have experience with multiple logist ...
-
Operations Supervisor
2 weeks ago
Suja Life LLC Oceanside, United StatesJob Description · Job DescriptionPosition Summary · The Operations Supervisor will be responsible for the day-to-day running of the Operations department. The Operations Supervisor will ensure that the Operations teams safely meet KPI goals. Work directly with the Shift Manager t ...
-
Operations Supervisor
2 weeks ago
Suja Life LLC Oceanside, United StatesPosition Summary · The Operations Supervisor will be responsible for the day-to-day running of the Operations department. The Operations Supervisor will ensure that the Operations teams safely meet KPI goals. Work directly with the Shift Manager to ensure all Operations goals ar ...
-
Production Lead
11 hours ago
Aerotek Oceanside, United StatesJob Title: Production Lead (2nd Shift)Job DescriptionAs a Production Lead for the 2nd shift, you will be the lead supervisor and primary point of contact for all production and assembly activities during your shift. Your responsibilities will include maintaining product and proce ...
-
Operations Supervisor
1 week ago
Suja Life LLC Oceanside, United StatesJob Description · Job DescriptionPosition Summary · The Operations Supervisor will be responsible for the day-to-day running of the Operations department. The Operations Supervisor will ensure that the Operations teams safely meet KPI goals. Work directly with the Shift Manager t ...
-
CNC Programmer
1 week ago
PEAK Technical Staffing USA Oceanside, United StatesESSENTIAL DUTIES AND RESPONSIBILITIES Contributes to continuous improvement & development projects Provides design for manufacturing/CNC process input for quote completion. Develops manufacturing processes by studying product requirements, creating programming geometry and tool p ...
-
Operations Supervisor
2 weeks ago
Suja Life LLC Oceanside, United StatesPosition SummaryThe Operations Supervisor will be responsible for the day-to-day running of the Operations department. The Operations Supervisor will ensure that the Operations teams safely meet KPI goals. Work directly with the Shift Manager to ensure all Operations goals are me ...
-
Material Handler II
1 day ago
MagnaFlow Oceanside, United StatesWho are we:Magnaflow is a leading manufacturer and supplier based in Oceanside, CA of premium products to the automotive aftermarket industry such as catalytic converters, performance exhaust and replacement exhaust. Through the Camburg division in Huntington Beach, CA. Magnaflow ...
-
Seamstress Operator
3 days ago
SUPERIOR FOAM PRODUCTS INC Oceanside, United StatesJob Description · Job Description · Sewing machine operators use industrial sewing machines to stitch together fabric and create clothing, textiles, or other products. They may work in various sectors, such as apparel manufacturing, upholstery, or automotive industries. · Familia ...
Manufacturing Supervisor - Oceanside, United States - TalentBurst
Description
Position: Manufacturing Lead/Supervisor (Manufacturing Technical Specialist)
Location: Oceanside, CA (100% onsite)
Duration: 8 Months Contract (through the end of 2024, with potential extension based on the development and achievement of deliverables)
Job Description:
The client founder of the biotechnology industry is dedicated to pursuing groundbreaking science to Client and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought, and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve.
Job Summary
The Manufacturing Technical Specialist is an integral member of the OSUT (Oceanside Single Use Technology) team in Oceanside. The OSUT is designed to be a state-of-the-art large molecule drug substance facility that supports GMP production for phase 3 clinical trials and commercial products. The OSUT will employ a ballroom design, and utilize single-use technology, new analytical techniques, and digital manufacturing systems to deliver a best-in-class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. The ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production. The team members will work closely with the existing staff in the stainless-steel operations as well as with the South San Francisco Clinical Supply Center (CSC).
In this role, the qualified individual will be part of the Operations, Process Support, and Process Engineering team that starts up the facility. There will be one team that will support the entire process from the initial cell bank thaw through the bulk freeze. Team members will support manufacturing operations upstream and downstream but will also have responsibility for technical evaluations, troubleshooting, and work with the project team on equipment or consumable design. The candidate will engage with customer groups, network teams, and project teams to seek opportunities for collaboration, proactively communicating and presenting information and offering relevant data-driven information to impact decisions.
Duration and Potential Extension:
The role requires a 100% time commitment at site Oceanside through the end of 2024, with potential extension based on the development and achievement of deliverables.
The high-level work outcomes are:
Deliverables and Milestones
Primary Responsibilities:
Qualifications:
Target Experience & Knowledge:
Prefer experience: knowledge of working with Single-Use Technologies or modular operations.
Skills & Competencies:
