Perform Commissioning, IQ, OQ and PQ activities for process equipment and utilities. This will include protocol preparation, scheduling, protocol execution, data analysis and authoring final reports.
Develop/improve validation programs as needed to remain current with cGMPs and industry standards.
Author and revise a variety of documents (e.g., Batch Records, SOPs)
Participate in meetings with management, operation and maintenance, design and construction personnel to understand project goals and schedule to ensure commissioning is properly coordinated.
Serving as validation representative for laboratory instruments and partnering with scientists, quality, and management on implementing new instruments at the site.
Initiates and leads risk assessment, gap analysis and deviation management for commissioning of laboratory equipment
The Ideal Candidate would possess:
1-3 years pharmaceutical related experience with degree.
Validation experience in pharmaceutical processes is preferred.
Good working knowledge of regulatory requirements
Experience with laboratory and/or manufacturing instruments/equipment required
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 degree in biology, biochemistry, biotechnology, chemical engineering, or biochemical engineering discipline
Work will include periodic evening and/or early morning weekday hours as well as weekend hours
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.
