Project Manager - Lab Information Systems

Information Technology / Computers

Project Manager - Lab Information Systems

Position: Full Time

Level: Mid/Senior

Salary Range: Unspecified

Company: West Pharmaceutical Services

Location: Lionville, PA

Website: Unspecified

Areas of Responsibility:

West Monarch Analytical Laboratories in Lionville, Pennsylvania (a suburb of Philadelphia) has an immediate opportunity for a Project Manager. Working closely with our Information Technology group, our analytical laboratories in Lionville, PA and Maumee, OH, and West plants, the Project Manager will develop and implement validation strategies in compliance with CFR 21 Part 11 for the expansion of Beckman LIMS, connecting the Lionville laboratories and the plant laboratories. The Project Manager will ensure timely completion of various tasks for completing the validation and implementation of the expanded LIMS and will act as the "go to person" for LIMS applications and users. The Project Manager will manage all other ongoing and future lab needs and projects requiring software and hardware validation including support from Information Technology, purchasing and vendors. Among different groups, the Project Manager will act as a liaison and an effective project manager.

Responsibilities:

Coordinate validation activities related to the current LIMS and its expansion.
Develop tests scripts and the required documents such as users’ requirements and master validation plan. Execute the validation plans and write reports, if needed.
Provide ongoing help to LIMS users in resolving issues and assist in developing new LIMS applications.
Develop SOPs and train lab personnel for enhancing compliance.
Coordinate and manage all other labs’ ongoing and future validation and compliance projects/needs efficiently and in strict cGMP compliance.
Work with the MIS group and carry out the roles and responsibilities assigned to labs. Present labs needs to the MIS group whenever assistance is needed.
Demonstrate good project management skills, coordinate the activities of project team members (LIMS team or CFR 21 Part 11 Compliance Team) and follow-up.
Work closely with Lab Systems Administrator.
Assist in validating other computerized lab instruments, risk assessment and remediation, etc.
Provide leadership in validating instruments, processes and systems including IQ, OQ, PQ.
Accept other responsibilities as needed.
Adhere to cGMPs.

Basic Qualifications:

BS degree in Chemistry or related field. Three to four years of analytical laboratory experience in a cGMP environment. Familiarity/working knowledge of various analytical instruments such as HPLC, GC, FTIR, UV. Experience with computer system validation including creation and execution of IQ/OQ/PQ protocols and a good understanding of cGMP and CFR 21 Part 11 Compliance. Experience with Beckman LIMS including LIMS builder and Forms builder preferred. Strong project management skills preferred.

To apply:

Send your resume or letter of qualifications to: fred.burris@westpharma.com