Process Engineer

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.

The Process Engineer (PE) has the responsibility to:

• Author and review GMP documentation, for example:
  • Standard Operating Procedures (SOPs)
  • Batch record modules
  • Technical Protocols, reports, or position papers
  • Executable batch records
• Provide support to the process team in the formulation and filling of clinical liquid drug product supplies.
• PE support includes (but is not limited to): pre-execution readiness activities (label generation, generating summary of components & assemblies required for manufacture, authoring or issuance of batch documentation), sample delivery, and clinical product delivery.
• Review executed batch documentation for adherence to good manufacturing practices and batch instruction
• Own change control records for equipment or process changes; PE must effectively collaborate with stakeholders to assess impact, identify deliverables, and manage change implementation.

• Perform deviation management, including authoring of events, assessment of impact, investigation of root cause, and identification of corrective & preventative actions.
• Drive process improvement projects in documentation, knowledge management, or shopfloor related activities.
• Qualify for aseptic gowning, as required per assigned work.

This role is on-site 5 days/week

Basic Minimum Qualifications:

• Bachelor’s/Master’s degree in engineering, biomedical engineering, chemistry, biology, or related field
• Minimum of 2 years in a technical or operations support role
• Knowledge of Good Manufacturing Practices
• A driver’s license which is valid within the United States
• Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications:

• Experience with project management, change control, or deviation management
• Experience with sterile process manufacturing and/or formulation development
• Analytical problem solving skills
• Cross-functional leadership skills
• Strong technical writing skills and have experience with batch documentation, investigations, and/or protocols

This position is Full-Time, Monday-Friday, for 40 hours a week (core hours 9am to 3pm - 8hrs per day expected around core hours) on site at West Point PA with over time as needed. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

• Excellent full time benefits including 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.