Project Manager QA Validation (Fill Finish Oversight) - BioSpace : Job Details

Job DetailsWe are looking to fill a Project Manager Validation (Fill Finish Oversight) position to our growing team. This position is responsible for providing quality oversight of validation and qualification of equipment, systems, and processes in accordance with regulatory requirements. In this role, a typical day may include:

• Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.

• Generates implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.

• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

• Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.

• Reviews, edits, and approves change control and SOPs.

• Collaborates with functional departments to resolve issues.

• Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Reviewing and providing quality oversight of validation activities including but not limited to: Shipping, Equipment, and QC processes.

• May trains/advise less experienced personnel.

• May directly supervise contingent workers.

• Provides direction and assigns work to full time employees and contingent workers to meet goals and deadlines. Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Manage and drives projects and programs.

• Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g., SIP Qualification, Cleaning Validation, Lab Equipment Qualification, Cleanroom Qualification)

• Must be able to present in a pressure test scenario the technical area that they are SME for

• May present at both internal and external (regulatory) audits

This role might be a fit for you if you:

• Have previous quality or process validation experience in DP or LDP preferred

• Are excited to work in a start-up environment

• Have validation experience in a GMP environment; drug product validation experience preferred

• Have a continuous improvement mentality to identify and implement improvement opportunities

To be considered for this role you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences and the following minimum amount of relevant experience to the role for each level:

• Project Manager QA Validation: 10+ years

• Sr Project Manager QA Validation: 12+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. #REGNQA Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.Salary Range (annually)$104,300.00 - $199,000.00