Support pilot plant operations for the GMP manufacturing of sterile, biologic, and vaccine clinical supplies. Interfaces with a large network including multiple research, commercialization, commercial supply, and other pilot plants teams
Lead and/or participate in various pilot plant process improvement projects with respect to compliance, efficiency, etc., working with cross-functional teams (e.g. operations, engineering, EM, quality, etc.)
Conduct investigations of minor deviations (NOE's) and author associated reports.
Create and review logbooks and other GMP documentation; collaborate with hourly and salary staff for corrections as needed.
Review utility reports and troubleshoot as necessary
Manage/maintain department production metrics
Support GMP, safety, and training initiatives
The Ideal Candidate would possess:
Analytical problem solving skills
Cross functional leadership skills
Technical writing experience - including batch documentation, investigations, protocols
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
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
Sterile process manufacturing and/or formulation development
Knowledge of manufacturing equipment and Good Manufacturing Practices
Project management
Authorization to work in the United States indefinitely without restriction or sponsorship
What we offer:
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
Position is full-time, Monday through Friday, 8 a.m. to 5 p.m., with the ability to flex hours as needed to support manufacturing. Position will support manufacturing operations, therefore weekend and holiday work may be necessary. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply. Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.
To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com .
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
