Posted in Other 15 days ago.
We are currently looking to fill an Associate Manager, Engineering & Automation Compliance position. This position is responsible for supervising a team of Engineering and Automation Compliance Specialists that runs deviation investigations, implements Corrective and Preventive Actions (CAPA), supports regulatory inspections, authors SOP and Life Cycle Documentation, facilitates change controls, as well as other compliance tasks/functions.
In this role, a typical day might include the following:
• Ensuring training, development, and compliance of team
• Setting priorities for Engineering Compliance department
• Supervising progress on Engineering quality system work, including deviation investigations, CAPAs, and change controls, ensuring quality and accuracy of documentation and alignment to due dates
• Providing tracking and trending of compliance activities (ex, change controls, investigations, corrective and preventive actions) and other compliance metrics for the Engineering department
• Interfacing regularly with Quality Assurance, Automation, Manufacturing, Facilities, and other functional areas to facilitate decisions pertaining to quality system work
• Performing and supporting investigations and root cause analysis for equipment-related and compliance-related events
• Owning change controls and interpreting testing requirements based on technical documents
• Developing and updating departmental policies, Standard Operating Procedures, Work Instructions, Job Aids, System Design Specifications, and Equipment Specifications
• Evaluating systems and processes for consistency to cGMPs and industry standard methodologies, and implement changes/improvements as needed
• Acting as a liaison between Engineering and Quality/Regulatory groups to address compliance-related items
• Facilitating and/or assisting in preparation of regulatory inspections
This role might be for you if you have:
• Direct experience with biopharmaceutical process equipment
• Proven leadership and project management skills with demonstrated track record of effective supervision of technical personnel
• Excellent interpersonal, written, and oral communication skills
• Detailed knowledge of GxP, CFR, and other regulatory requirements
To be considered for this role you must hold a Bachelor's degree in Engineering and 6+ years of relevant experience working in a cGMP environment or in a regulated industrial facility. Equivalent combination of education and experience may be considered.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.