Sterile Pilot Plant GMP Specialist at Eurofins Lancaster Laboratories Professional Scientific Services, LLC in West Point, Pennsylvania

Job Description:

Sterile Pilot Plant GMP Specialist



Employee Responsibilities:

• 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.)
• Revise/author GMP documentation (e.g. SOP's, logs, 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.


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