Lead Manufacturing Associate-LAN

Emergent Biosolutions•Lansing, MI

7d•$61,000 - $73,900•Onsite

About The Position

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. This role executes tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. The Lead Manufacturing Associate will complete training and maintain competence per the manufacturing training program and actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities.

Requirements

HS Diploma
Minimum of 4 years of experience working in a cGMP environment
Knowledge and understanding of cGMP and CFR requirements
Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware
Able to work independently with limited supervision
Strong mechanical aptitude as determined by trainer assessment

Nice To Haves

working collaboratively with others, communicating, and managing conflict effectively
cultivating innovation and nimble learning
ensuring accountability, and making good and timely decisions
demonstrating courage and focusing on customers
gaining the confidence and trust of others through honesty, integrity and authenticity
making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem
plan and prioritize work to meet commitments aligned with organizational goals
creating a climate where people are motivated to do their best to help the organization achieve its objectives

Responsibilities

Complete training and demonstrate competency on Lead Manufacturing Associate qualification blocks in accordance with the training progression pathway.
Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures.
Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook.
Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per Standard Operating Procedures.
Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform “real time” review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift.
Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials.
Perform bubble point integrity testing of hydrophilic and hydrophobic production filters using defined test programs.
Ensures that all Batch Production Records are requested and obtained in accordance with the production schedule.
Verification of Facilities department execution of preventive maintenance of equipment. Requires thorough understanding of GMP equipment operation and function for intended purpose.
Proactively recognize potential issues with manufacturing process equipment and troubleshoot in collaboration with Facilities/Maintenance.
Make decisions and escalate manufacturing and quality issues to management in a timely and effective manner.
Participate in self inspections and 6S audits and respond to findings.
Show personal commitment and acts to continuously improve.
Builds networks and engages in/runs meetings.
Holds self-accountable as well as peers.
Displays strong core values and cultural responsibilities.
Capable of scheduling and coordinating daily tasks.
Contribute to the development and promotion of standard work.
Collaborate with applicable Integrated Process Teams to drive continuous improvement and learn new Lean concepts.
Oversee and actively participates in Kanban and 6S systems.
Identify continuous improvement opportunities and collaborates with Integrated Process Teams and Supervisors to drive initiatives through to completion.
Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification).
Independently operate labeling equipment with minimal supervision (Qualification).
Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation).
Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging).
Complete ambient tracking documentation.
Execute material issuance and confirmation of process steps using specific SAP modules.
Precisely weigh and hydrate media components.
Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures.
Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts.
Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV).
Prepare and dispense intermediate materials.
Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls. Process operation involves manual orientation of valve configurations and monitoring/adjustment of vessel pressures during execution to maintain the sterile envelope and create differentials to facilitate transfers.
Clean and Sterilize 10L, 120L and 1320L fermenters to defined and validated parameters through interface with automated control system.
Sterilize media filters and sterile filter seed, intermediate and production media.
Prepare and dispense Saline for Inoculum for 10L fermentation initiation.
Inoculate 10L fermenter through addition of inoculum via peristaltic pump.
Monitor culture turbidity to verify growth to required process parameters and transfer culture from the 10L to 120L and the 120L to 1320L fermenters upon verification of achievement of these parameters.
Adjust pH of culture through manual addition of 2N NaOH aliquots to a defined pH range.
Install sterilizing grade filters, perform integrity testing and execute sterilization of filter skid.
Monitor culture turbidity to verify growth to required process parameters and filter culture from 1320L fermenter to Harvest Tank.
Add ALOH to Harvest tank.
Draw samples and submit them through LIMS.
Clean and sterilize Harvest Tanks.
Clean and sterilize centrifuge as well as run the centrifugation processes.
Dispense and sterilize ALOH.
CPG addition.
Final Filtration.
Initiate Non-Conforming Events and perform/document all necessary containment activities. Accurately complete triage assessment tool and proactively assist NCE author with investigation.
Escalates non-conforming events to Manufacturing leadership in real-time to ensure appropriate containment and immediate corrections are completed.
Initiate changes in the change control system regarding periodic review document revisions.
Revise existing procedures in the document management system.
Assist author with investigation of root cause, impact assessment and identification of durable corrective and preventive actions.
Train all levels of associates - Complete and maintain Qualified Trainer training qualification. Qualification includes strategies for trainee motivation and competence development, adult learning principles, step by step training guide and proper documentation of all activities to ensure crediting of qualification status.