Partnering with laboratory end users, quality support, lab computing, and instrument vendors to lead specific computerized systems validation activities (analytical instrumentation in a large molecule laboratory setting)
Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in BVA laboratories.
Initiates and leads risk assessment, gap analysis, and deviation management associated with the installation, qualification, and validation of various laboratory instruments.
Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument. Previous experience with PR/CAPA systems preferred.
Able to understand and follow procedures
Participate in regulatory agency and internal audits
All other duties as assigned.
The Ideal Candidate would possess:
Familiarity with system validations and associated regulations (21 CFR Part 11 Compliance)
Hands on experience operating computerized instrument systems.
Demonstrated attention to detail.
Must be able to work independently.
Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).
Familiarity with enterprise systems such as but not limited to Empower, Labware LIMS, Expressionist, and LINK.
Demonstrated ability to work in a team environment and manage workload to meet deadlines.
Excellent communication skills both oral and written
Strong organization and attention to detail
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies (GMP knowledge a plus)
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Minimum Qualifications:
Bachelor's degree in a science or engineering related discipline with knowledge in quality operations laboratory processes.
At least 4 years of experience in the validation of analytical laboratory systems, preferably in the Pharmaceutical industry.
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
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.
