Bachelor's degree in engineering, IT, or related field with 2+ years of relevant experience, or a Master's degree.
Authorization to work indefinitely without sponsorship.
Previous leadership experience in a laboratory setting.
Experience in GLP or GMP environments, preferably bioanalytical.
Proven track record in validation activities and quality functions.
Responsibilities
Collaborate with information teams and security organizations for compliant lab support.
Support lifecycle management of GxP equipment from acquisition to retirement.
Apply expertise in computer system validation for laboratory equipment.
Maintain service schedules for instrument calibration and maintenance.
Coordinate service activities with vendors and facilities staff.
Serve as system administrator for equipment applications and temperature monitoring systems.
Engage in routine operations to promote continuous improvement.
Benefits
Comprehensive medical, dental, and vision coverage.
Life and disability insurance.
401(k) plan with company match.
Paid vacation and holidays.
Full Job Description
Job Description
Collaborate with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure compliant laboratory support of regulated bioanalytical laboratory programs
Support the lifecycle of GxP equipment including the acquisition, installation, maintenance, and retirement phases.
Apply deep expertise in the computer system validation process for diverse laboratory equipment such as automated liquid handlers, plate readers, and PCR systems.
Maintain service schedules for instrument maintenance, ensuring timely completion of calibration and maintenance activities in accordance with departmental SOPs.
Coordinate service activities involving various vendors, service engineers, and facilities staff, fostering strong professional relationships.
Develop a working knowledge of laboratory equipment, like liquid handlers, plate washers/readers, and PCR.
Serve as system administrator for equipment applications, including temperature monitoring systems, assisting in the management of controlled temperature units and alarm handling.
Collaborate with lab ops staff across bioanalytical labs and sites for process improvement, cross-training and cross-site support.
Engage in the routine operations supports promoting a culture of continuous improvement.
Assist in the development of reporting, analytics and visualization solutions to support local clinical operations and administrative business processes.
Ensuring automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements.
Reviewing documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GxP Practice and corporate safety requirements.
Enhance the existing LAMP infrastructure to track equipment preventative maintenance (PM) within the client's department.
Provide compliance support activities such as entering PM and corrective maintenance services in the electronic laboratory logbook.
Oversee outsourced pipette calibration, maintaining records in the electronic logbook. Generate and review out-of-calibration impacts reports, share it with management and take appropriate actions.
Perform Hamilton verification after PM/CM, documenting verification in the electronic logbook.
Utilize technical knowledge to ensure efficient operation of various automated processing and informational technology systems.
Participate in compliance audits and training programs.
Providing client services support for business area laboratory applications.
Leadership Responsibilities:
Act as a technical resource, trainer, and troubleshooter for the department
Make recommendations for operational and/or technical improvements
Communicate effectively within the group
Coach and develop direct reports
Plan and monitor workflows
Monitor and approve employees' time worked through time-entry system
Support and promote company policies and procedures
The site is not accessible by public transportation routes/options.
Qualifications
Minimum of a Bachelor of Science degree needed (with a minimum of 2 years of relevant experience) or a Master's degree in engineering science, Information Technology or a related field.
Authorization to work in the country indefinitely without sponsorship.
Previous leadership experience
Required skills
Experience in a GLP or GMP laboratory, preferably in a bioanalytical setting.
Proven experience in validation activities and associated Quality functions.
Demonstrated strong interpersonal skills with the ability to influence others and promote a culture of inclusion, feedback, and empowerment.
Highly organized, and multitasking capabilities to manage multiple equipment or system schedules, documents, and maintenance tasks.
Strong verbal and written communication skills, with comfort in interacting with diverse on-site and off-site collaborators.
Ability to follow Standard Operating Procedures with insight into continuous improvement.
Apply general knowledge of company business developed through education or experience.
Understand and apply regulatory/ compliance requirements relative to the role.
Problem solver/troubleshooter, skilled in Root Cause Analysis (RCA).
Additional Information
Position is full-time, Mon-Fri 8am-5pm. Candidates currently living within a commutable distance of Spring House, PA are encouraged to apply. The site is not accessible by public transportation routes/options.
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
About Eurofins Lancaster Laboratories
Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
