Execupharm FSP CMC-Validation Specialist Scientist II

B.S. Degree in Chemistry, Biochemistry, or closely related sciences with at least 3 years of industry experience or an M.S. with at least 1 year of related experience.

Must be able to go to 2 locations, West Point, Pa and Rahway, NJ-will be compensated Responsible for the oversight of all validation activities on regulated laboratory instrumentation Oversee the validation lifecycle of the lab instrumentation including instrument software assessments, drafting and execution of validation documentation, leading/working on cross-functional teams to ensure projects are seen to completion, and applying all current data integrity standards to laboratory instrumentation

Position responsibilities : Participate in and lead cross-functional teams supporting computer system validation activities associated with new or upgraded instruments or software packages Serve as a business area representative on all validation projects and communicate timelines, issues, and expectations with all appropriate parties Draft, execute, and approve validation documentation applying to a wide variety of lab-based instruments Work with quality assurance partners and ensure all current data integrity standards are applied to laboratory instrumentation Coordinate troubleshooting activities with site-based IT support and/or external service providers Gain a working knowledge of laboratory instruments/software to facilitate with troubleshooting and/or perform validation activities Participate in drafting or updating standard operating procedures (SOPs) to ensure all computer system validation requirements are met and applied

Required Experience and Skills: Experience working within a regulated (GMP) laboratory Familiarity with standard computerized laboratory instruments including disintegration testers, moisture analyzers, UVs, particle analyzers, and other automated computerized laboratory systems Familiarity with GMP and Part 11 standalone computer system validation requirements (vendor will run validation on vendor software; looking for candidate to be interface for standalone computer systems validations). Understand the components of a Validation Mast Plan (VMP) and the various documents associated with validation of computerized systems and in particular stand-alone systems. Compliance minded individual who understands who to write qualification protocols in a way that ensure compliance with Part 11 and corporate documentation SOPs. Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks Capable of working independently under moderate supervision Strong verbal and written communication skills Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators Looking for someone who will take initiative and show enthusiasm in working with instruments Looking for candidate who will enjoy and want to grow in this position

Preferred Experience and Skills: Experience with standard analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolutions. Experience with computerized standalone systems GMP validation requirements QualificationsB.S. Degree in Chemistry, Biochemistry, or closely related sciences with at least 3 years of industry experience or an M.S. with at least 1 year of related experience. Responsible for the oversight of all validation activities on regulated laboratory instrumentation Oversee the validation lifecycle of the lab instrumentation including instrument software assessments, drafting and execution of validation documentation, leading/working on cross-functional teams to ensure projects are seen to completion, and applying all current data integrity standards to laboratory instrumentation

Position responsibilities : Participate in and lead cross-functional teams supporting computer system validation activities associated with new or upgraded instruments or software packages Serve as a business area representative on all validation projects and communicate timelines, issues, and expectations with all appropriate parties Draft, execute, and approve validation documentation applying to a wide variety of lab-based instruments Work with quality assurance partners and ensure all current data integrity standards are applied to laboratory instrumentation Coordinate troubleshooting activities with site-based IT support and/or external service providers Gain a working knowledge of laboratory instruments/software to facilitate with troubleshooting and/or perform validation activities Participate in drafting or updating standard operating procedures (SOPs) to ensure all computer system validation requirements are met and applied

Required Experience and Skills: Experience working within a regulated (GMP) laboratory Familiarity with standard computerized laboratory instruments including disintegration testers, moisture analyzers, UVs, particle analyzers, and other automated computerized laboratory systems Familiarity with GMP and Part 11 standalone computer system validation requirements (vendor will run validation on vendor software; looking for candidate to be interface for standalone computer systems validations). Understand the components of a Validation Mast Plan (VMP) and the various documents associated with validation of computerized systems and in particular stand-alone systems. Compliance minded individual who understands who to write qualification protocols in a way that ensure compliance with Part 11 and corporate documentation SOPs. Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks Capable of working independently under moderate supervision Strong verbal and written communication skills Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators Looking for someone who will take initiative and show enthusiasm in working with instruments Looking for candidate who will enjoy and want to grow in this position

Preferred Experience and Skills: Experience with standard analytical instrumentation such as HPLC, UPLC, GC, UV, IR, Karl Fischer, and dissolutions. Experience with computerized standalone systems GMP validation requirements EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.