Connexion strives to be the unrivaled staffing solution for both job seekers and hiring organizations by expertly connecting talent with opportunity. We build world class teams for our customers, and better the lives of our candidates by providing them with fulfilling careers.
Connexion would like to provide you with details about this new opportunity as we are seeking individuals with the following skills:
SENIOR ENGINEER – MS&T
CORRECTIVE AND PREVENTIVE ACTION
MAMMALIAN CELL CULTURE
- The process engineering team is tasked with improving the maturity, scale & efficiency of manufacturing processes
- Key initiatives include: capacity expansion, process scale-up activities, site transfers and critical pieces of new product introductions.
- Sr. Engineer will work with Scientists & Specialists within MS&T, partnering W/ R&D, Quality, Production & other engineering groups to develop processes for new products, sustain & improve processes for existing products within Manufacturing areas: Fermentation, Purification, Bulk Fill or Technical Services.
Initiate & lead process equipment improvements, onboarding & purchase of new equipment & investigation studies. Coordinating vendor visits for onsite service, work w/instrumentation group for other calibration events.
Leads technical support to commercial manufacturing group for routine manufacturing processes
Evaluates new technology & implements new process equipment into GMP manufacturing
Provides guidance to staff with production support activities including pre-production checks & equipment testing activities
Design & execute system/equipment-based studies to screen, optimize, & scale production processes, analyzes & interprets results, participates in process improvement, development, scale up & qualification activities.
Ability to troubleshoot new & existing product or process issues related to yield, quality & throughput, utilizing structured problem-solving techniques & quality assurance mechanisms
Work closely with process characterization teams to assure process reliability & robustness in preparation for comparability & process validation
Prepares equipment related operating procedures and/or relevant engineering documents (SOPs, protocols & reports for FATs, comparability, manufacturing process validation testing), including data interpretation & communication of technical results.
Provide technical support for new products to site including process/equipment feasibility assessments, process & equipment requirements
Supports all QA Compliance investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management
Supports FDA & other Regulatory inspections
Ability to own & drive change control records for the department to support departmental projects & assigned CAPAs.
Participates in projects associated with process equipment, process improvements, design, start-up, commissioning & qualification of new investments.
Ability to lead process technology transfers from other depts. to increase the effectiveness of Manufacturing processes
Partners & collaborates w/site Project Management organization with higher level, long term initiatives
Ensure successful manufacturing process comparability & process validation runs by assessing risk, setting preventative measures, investigating & troubleshooting equipment/process related issues
Required Skills & Abilities:
TOP 5 TECHNICAL SKILL SETS REQUIRED:
- Project management
- Equipment onboarding, commissioning, and validation (IQ/OQ/PQ)
- Technical writing (SOP creation)
- Equipment troubleshooting/problem solving.
- Background in Mammalian cell culture or familiarity with single use bioreactors and new facility startup.
• Strong technical expertise in biotech unit operations & equipment, especially in the area of protein production & protein purification
• Advanced working knowledge & experience in cGMP environments (understanding of equipment, technology, & quality systems requirements)
• Experience with project design, construction, start-up, commissioning & validation as well as leading & supporting factory acceptance tests & site acceptance
• Experience with automated equipment engineering & validation
• Experience supporting FDA & other Regulatory inspections
• May be required to work periodically out of normal business hours
• Must be self-motivated, detail-oriented, collaborative, & able to work effectively in a fast-paced environment.
• Must be able to work independently, manage multiple priorities, with the ability to prioritize & complete activities on time
• Demonstrated effective communication, oral & written, in a multi-disciplinary, project-driven work environment.
• Attention to detail, strong organizational skills, the ability to multitask, & effective interpersonal & communication skills are required.
• 5S, OpEx, & Lean manufacturing experience a plus
BS in Engineering (Mechanical, Electrical, Chemical, Bioengineering) or Biology, Chemistry, or similar field. 7-10 years’ experience.
Date Posted: 3/11/2020
Hiring Organization: Connexion Systems & Engineering
Job Title: Senior Engineer – Manufacturing Science & Technology
Location: Emeryville, CA
Employment Type: Full Time, Contract
Pay Range: 80-82/hr.
Duration: Long Term Contract
Job #: bh11181
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776