the manufacturing operations support engineer will provide on floor technical support to manufacturing operations, work with investigation teams in solving complex manufacturing issues, identify opportunities to improve manufacturing processes and cgmp documentation and analyze manufacturing process control data.
• provides daily on-the-floor technical support to manufacturing operations.
• write and review batch records.
• identify areas of process risk identify, assess, and implement risk mitigation strategies.
• tracks, trends, and communicates process performance.
• leads process validation and verification efforts.
• possesses an understanding of the principles related to the validated states of the process and process equipment.
• promote “right first time” philosophy for all manufacturing activities.
• provide technical training to manufacturing personnel.
• participate in change controls and product deviation investigations.
• ensures manufacturing staff identify and document events that deviate from normal operation.
• provide technical support to deviation investigations.
• completes investigations, reports, and proposes capa for minor deviations.
• supports plant floor continuous improvement initiatives (process and value stream mapping).
• supports the creation manufacturing sop’s that ensures manufacturing operations stay aligned with the validated process.
• bs in chemical or biochemical engineering (or similar) with 0-2 years manufacturing floor experience.
• demonstrated understanding of biologics manufacturing, scale-up and validation principles.
• excellent problem solver and ability to generate innovative solutions to broad range of issues.
• good understanding of experimental design and statistical process evaluation.
• ability to explain complex technical issues to other functions in clear and understandable terms.
• familiarity with one or more upstream or downstream process unit operation design typically used in biotech manufacturing (cell expansion, fermentation & cell culture, harvest / clarification, purification).
• previous experience with process or equipment validation
• ability to evaluate new technologies/techniques.+11 Other Responses
Biotech Engineering Design And Construction
"engineering design and construction–sourcing best practices for vaccines/biotechnology industry"
in-house vs. Outsource:
• how do companies deal with the engineering offices category for vaccines/biotech categories across germany, italy, hungary, uk and usa? (in-house or outsource)?
• what is the widely adopted execution model for this category? (complete in-house, epc, epcm, gc+e&a etc.)
• what are the key dependent factors considered in this regard to decide on using the outsourcing model?
O type of engineering and construction services (basic scheme/design, procurement, construction management and contracting etc.)
o package (groundworks and external works, cleanroom, hvac, building services, electricity, process equipment etc.)
• how do companies source their engineering office services across germany, italy, hungary, uk and usa? (centralized or decentralized)
engagement strategy and contracting:
• how do companies engage with the engineering office suppliers?
O global/regional/local engineering offices
o single/multiple engineering offices
o factors that determine the choice of strategy
• what are the contracting models followed with these suppliers? (reimbursable, lumpsome etc.)?
• what is the duration of the partnership between the clients and the engineering offices?
• what is the cost structure for the key disciplines used in the engineering offices category across germany, italy, hungary, uk and usa?
• who are the top engineering office companies across germany, italy, hungary, uk and usa+4 Other Responses
Hi zintro expert,
the zintro blog needs you! we are looking for expert opinions on the news mentioned below and would like to include your point of view. We realize your time is valuable, so here is a brief summary of what we are looking for:
*a brief answer to the prompt about 1-2 paragraphs including your full name
*participation is voluntary no payment will be involved
*if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you
topic and prompt
biotechnology needs more visibility, biogen idec says, and the biogen idec foundation is looking to help out with a $1.5 million grant.
The biogen idec foundation is teaming up with the association of science-technology centers, or astc, to launch the world biotech tour, which “aims to increase the impact and visibility of biotechnology among youth, the general public, and underserved communities to promote science literacy,” the two groups said in a press release.
The world biotech tour, or wbt, will also feature an international ambassadors program that will enlist a group of middle and high school students from around the world to “support and inspire others to participate in the wbt in their communities and schools. Throughout the tour, the biogen idec foundation and astc will conduct research on how biotechnology is being taught to the public, both in schools and outside of the classroom.”
astc represents nearly 500 science centers and museums across in 46 countries, including the us.
The first three stops of the tour are set for belgium, portugal, and japan, the release said.
“the biogen idec foundation is committed to furthering efforts that promote the drive, dedication, creativity and educational excellence of future scientists,” tony kingsley, chairman of the biogen idec foundation, said in a statement. “with the growing need for developing tomorrow’s stem workforce, we are glad to partner with the astc to help to achieve this goal.”
what are your thoughts?
Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name.
If you have any questions, please let us know.
the zintro blog team
wondering what the post would look like? Here is a sample:
/>+2 Other Responses
I need to hire a molecular biology consultant for a future project.
I live in northern california and im looking to recruit a molecular biology consultant for a project pertaining to genetic engineering+32 Other Responses
We seek a highly motivated candidate to join our r&d team. This incumbent will be responsible for managing the biological systems function for r&d. The role will participate in new product development with a focus on high speed, non-contact dispensing for biological applications.
work independently and as a member of cross-functional teams to support research and development by test and verification of new instruments, capabilities, consumables, workflows, and automation platforms
motivate and lead teams of scientists and engineers to accomplish technology and product development goals
be a technical leader and team player in a multidisciplinary environment
mentor and directly supervise biological systems staff
contribute with hands-on participation in the development of molecular biology and chemistry methods to support company growth
work closely with team members to ensure alignment and efficiency in designing and planning development efforts and plan execution
align development plans and project timelines to deliver product design requirements successfully
provide staff with technical guidance and training, as well as identifying resources needed to meet or exceed project goals
lead process troubleshooting efforts and optimization, and identify opportunities for product development process improvements in the biological systems team
demonstrated ability to solve problems independently, run experiments, analyze data, interpret results and modify procedures, present results in public and maintain experimental records
ph.D. In biochemical/ chemical/ biomedical or bio engineering, molecular biology/ biochemistry/ chemistry or related field with 4+ years of industrial experience or a master’s degree in equivalent majors with 7+ years of industrial experience required
hands-on experience in standard molecular biology techniques including dna sample preparation, genomic assay technologies, qpcr and pcr required
experience with technology and product development including leading projects from concept to commercial release
experience in quantitative assay development related to molecular biology and genomics
hands-on experience with next generation sequencing development
hands-on experience with roche (454), illumina miseq and hiseq, pacbio or ion torrent sequencing platforms
desirable skills and attributes:
experience with laboratory liquid handling and automation equipmentexperience in bioinformaticsexperience with synthetic biology
experience working with bsl-2+ level human pathogens and human clinical material, including bacterial and viral pathogensexperience with matlab/ python
please attach your cv here to apply.+26 Other Responses
Startup Pe Biotechnology & Medical Fund Seeking A M&a Consultant / Partner.
We are a private equity firm with limited partnerships & capital partners seeking to acquire full ownership interests in 30-35+ medical & biotechnology companies with set parameters and investment criteria in a 12-18 month period.
We are seeking partnerships who have access to capital and we can retain their advisory services to grow the portfolio and get it ready to be acquired. We have identified a few predefined exits upon fully completion of the portfolio.
1. You will have to prospect and find ideal candidates for acquisitions on a daily basis.
2. Structure optimal acquisition strategy & terms to be presented to internal & external funds.
Ideal partnership will have access to capital parnters & dealflow of the companies that are prime candidate for acquisition and will be compensated via a retainer, bonus & equity.
Areas of expertise: seeking experts with knowledge of private equity lbo for medical & biotechnology companies.; private equity lbo for medical & biotech co; venture capital; private equity; leveraged buyouts; partner; advisory on m&a; capital raising+34 Other Responses
I work for a large chemical company. We are seeking to talk with experts about bio-based chemicals and intermediates - manufacturing and market knowledge+10 Other Responses
Looking for a scientist who has done research on dna microarrays, hybridization, and nucleic acid binding+26 Other Responses
I am looking to connect with one or more microarray experts for clarify my doubt concerning to calculate the fold level from raw data. I want to clear about p-values and fold level in gene expression data+8 Other Responses
Business Development In Biotechnology
We are looking for a business expert to help with business development and negotiation in a fast growing biotechnology company in northern california.
experience in biotechnological company and global sustainability, extensive global experience for growth and deployment.Experience in applying innovation and creativity to business development, negotiation and building alliances within the biotechnology, pharmaceutical
areas of expertise:
seeking experts with knowledge of business development in biotech; biotechnology and catapult the company into the next growth phase
note: since we look for a long tern relationship with qualified business expert, the phone interview would be required. Thanks.+39 Other Responses
Areas: molecular biology, oncology
tasks: smes will provide help for developing course materials and will also perform or support training for members of medical teams, molecular pathologists, phd level molecular biologists, biochemists, and medical device consultants.
Duration: apprx 6 months full time
location: us, but will need to travel across us and possibly germany & some other countries in europe as well
education / skill: ph.D. Or equivalent level in molecular biology / oncology with a fairly good academic / research track record. Should have good knowledge of us and european medical accreditation.+25 Other Responses
Microarray Data Analysis
I am looking for a microarray data analysis expert who has experience in gene expression class prediction algorithms for cancer transnational applications.+23 Other Responses