Pharmaceutical Manufacturing Support Engineer
Eurofins USA PSS Insourcing Solutions
Job Description
Job Description
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description- Lead equipment qualification activities according to industry standards to support drug product pharmaceutical manufacturing and R&D activities.
- Lead, facilitate, and participate in technical discussions to successfully resolve problems with equipment suppliers, methods, project issues, and deviations.
- Design, develop and deploy automation within manufacturing unit operations to ensure competitiveness and organizational excellence.
- Progress the technical understanding of process impact on drug product, ensuring consistent scientific excellence and scientific quality standards are met.
- Lead, support, and contribute to internal Fill/Finish activities in support of Lead Stability Development batch manufacturing. Responsible for ongoing production and continuous improvement initiatives.
- Opportunity to develop process engineering skills including the use of multiphysics software for process modeling and the statistical analysis of data.
Education:
- Minimum of a BS in Biomedical Engineering or relevant engineering concentration with 5 years of experience (including co-op, internships or industry experience) is required. MS with 2 years of work experience is preferred.
Qualifications:
- Experience in GxP automation equipment commissioning, qualifications, and life-cycle management are required.
- Experience and knowledge in GxP Fill/Finish applications is required
- Proficiency in sensors and signal conditioning, circuit design/analysis and automation control systems are preferred.
- Proven proficiency and experience in biologics (mAbs, gene therapies, cell therapies, etc.) within the pharmaceutical industry with a high level of technical understanding are preferred.
- Effective communication skills by delivering information across multifunctional groups/sites and demonstrated leadership in providing integration of activities s are required.
Authorization to work in the United States indefinitely without restrictions or sponsorship
Additional InformationPosition is full-time, Monday-Friday, generally 8 a.m. - 5 p.m ., weekend work might be expected. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.
Excellent full-time benefits include:
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
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