Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Ensures cGMP compliance for the Rensselaer Tech Ops Engineering & Automation Department.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Facilitates all reviews and revisions of Department related SOP's, plans and policies for each group within the Department.
- Acts as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address all compliance related items.
- Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.
- Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, NOE's, DNF's, impact statements and corrective action plans.
- Participates in investigations and root cause analysis for all department issues of non-compliance.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reorts (PER) logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.
- Provides tracking and trending for all maintenance related compliance activities i.e NOEs, PMs, and PERs.
- Participate in and obtain results of all department quality and regulatory audits.
- Specify and coordinate and training, OJT and SOP, for Automation, Engineering and contracted personnel.
- Provide periodic review of Facilities Department documentation and records such as logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.
- Follows current good manufacturing practices (cGMPs).
Knowledge and Skills:
- Current knowledge of cGMP operations, onsite regulatory and quality policies, procedures and documentation methods.
- Strong knowledge of Design Lifecycle and Quality Risk Management
- Must work independently and have project management capabilities.
- Cursory knowledge of technical terminology and jargon commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation.
- Strong leadership capabilities
- Good organizational skills.
- Ability to speak to large groups of people.
- Excellent writing and interpersonal skills.
- Working knowledge of word processing, spreadsheet, PowerPoint and database management software.
Education and Experience:
- Requires BA/BS (engineering or scientific related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of an industrial facility.
Title level (Associate, Mid-Level, or Sr.) will be determined based on skills and experience.
We offer a competitive compensation and benefits package including stock incentives, 401k with company match, as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all recruitment agencies:
Regeneron is using the agency management company, Candex - www.candex.com. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means.
Regeneron is an equal opportunity employer and is an affirmative action employer.
To apply for this position, please CLICK HERE