LansingRecruiter
the smart solution for Lansing jobs

Manufacturing Associate

Company: Emergent BioSolutions
Location: Lansing
Posted on: April 14, 2019

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities.

Responsibilities

Manufacturing Responsibilities

General

* Complete training and demonstrate competency on Senior Technician qualification blocks in accordance with the training progression pathway

* Maintain training/competence on Technician level job tasks in assigned areas and execute as required

* Execute and document procedural steps in compliance with cGMP standards, clean room behavior and aseptic technique 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 surfaces and equipment per Standard Operating Procedures

* Perform bubble point integrity testing of hydrophilic and hydrophobic production filters using defined test programs

* Review all documentation generated for accuracy of calculations, data entry 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

* Ensures that all Batch Production Records are requested and obtained in accordance with the production schedule

* Stock gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials

* Verification of Facilities department execution of preventive maintenance of equipment. Requires thorough understanding of GMP equipment operation and function for intended purpose

Leadership

* Proactively recognize potential issues with manufacturing process equipment and troubleshoot in collaboration with Facilities/Maintenance

* Escalate manufacturing and quality issues to management in a timely and effective manner

Lean Concepts

* 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 kan ban and 5S systems

* Identify continuous improvement opportunities and collaborates with Integrated Process Teams and Team Leads to drive initiatives through to completion

Inspection & Packaging

* Management of documentation and control of ambient exposure process time for drug product, final filled product and finished product

* Documentation of the examination and review of labels and labeling for conformity with established specifications and disposition of rejected components, drug product containers, closure, and labeling through use of SAP modules (Material Disposition)

* Successfully complete inspector re-qualification requirements to maintain ability to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)

* Acknowledge GMPH alarms and perform appropriate follow up to ensure impact to product is minimized

* 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)

Building 55 Operations Prep

* Execute material issuance and confirmation of process steps using specific SAP modules

* Precisely weigh 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 Clean Out of Place (COP) and Steam Out of Place (SOP) of production vessels through interface with automated control system

* Prepare and dispense Saline for Inoculum for 10 L fermentation initiation

* Prepare and dispense 2N NaOH for 100 L fermentation pH adjustment

Building 55 Operations Upstream

* 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. Description of specific requirements include:

* 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

* 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

Quality Systems

* 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 in regard to 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

Training

* Train all levels of technicians - Complete and maintain Qualified Trainer training qualification.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Keywords: Emergent BioSolutions, Lansing , Manufacturing Associate, Other , Lansing, Michigan

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


[Remote] Part-time Online Tutor for Children
Description: VIPKid Online English Teacher br br Looking for a flexible online teaching opportunity We are seeking passionate educators to teach English online to over 500,000 students in China - with the flexibility (more...)
Company: VIPKID
Location: Armada
Posted on: 04/22/2019

Current College Students - Stores Executive Intern Inland Empire
Description: DESCRIPTION: br ABOUT US: br One of the world's leading and most recognized brands comes to life in our stores, where guests are still captivated by everything that made them fall in love with Target. (more...)
Company: Target
Location: Ann Arbor
Posted on: 04/22/2019

[Remote] Part-time Online Tutor for Children
Description: VIPKid Online English Teacher br br Looking for a flexible online teaching opportunity We are seeking passionate educators to teach English online to over 500,000 students in China - with the flexibility (more...)
Company: VIPKID
Location: Washington
Posted on: 04/22/2019


Current College Students - Stores Executive Intern (Maryland, MD - Washington DC)
Description: One of the world's leading and most recognized brands comes to life in our stores, where guests are still captivated by everything that made them fall in love with Target. Our approximately 1800 locations (more...)
Company: Target
Location: Ann Arbor
Posted on: 04/22/2019

IT Delivery Lead
Description: Youngsoft is one of the fastest growing companies based out of Wixom Michigan providing IT services to various clients across the USA. currently we have a IT Delivery Lead position at one of our client (more...)
Company: Youngsoft
Location: Detroit
Posted on: 04/22/2019

Uber Eats Part-Time Delivery
Description: Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends-it's up to you. Earn Good Money. You'll earn by bringing people (more...)
Company: Uber Eats
Location: Saline
Posted on: 04/22/2019

Law Enforcement Transcriber - Work From Home
Description: Net Transcripts is looking for many vendors / independent contractors who have experience transcribing audio content of criminal investigations, court proceedings, law enforcement interviews, jail calls, (more...)
Company: Net Transcripts
Location: Livonia
Posted on: 04/22/2019

Uber Eats Part-Time Delivery
Description: Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends-it's up to you. Earn Good Money. You'll earn by bringing people (more...)
Company: Uber Eats
Location: Ann Arbor
Posted on: 04/22/2019

Operations Associate
Description: Job Description: Description We are genuine in our belief that sports make people better and so are you Immerse yourself in a workplace that loves to be active and lives the brand. Associates joining (more...)
Company: Dick's Sporting Goods
Location: Troy
Posted on: 04/22/2019

[Remote] Part-time Online Tutor for Children
Description: VIPKid Online English Teacher br br Looking for a flexible online teaching opportunity We are seeking passionate educators to teach English online to over 500,000 students in China - with the flexibility (more...)
Company: VIPKID
Location: Ypsilanti
Posted on: 04/22/2019

Log In or Create An Account

Get the latest Michigan jobs by following @recnetMI on Twitter!

Lansing RSS job feeds