Compliance Specialist (Engineering & Automation)

Location
Rensselaer, NY, United States
Posted
Aug 23, 2019
Ref
17443BR
Required Education
Bachelors Degree
Position Type
Full time
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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Ensure and support cGMP and procedural compliance for the Rensselaer Technical Operations Engineering & Automation Department. Evaluate instrumentation, equipment, and system documentation against business expectations, regulatory standards and procedural requirements. Analyze for trends, forecast measurements and identify/manage continuous improvements.

Level to be determined based on qualifications relevant to the role.

Essential Duties and Responsibilities: include, but are not limited to, the following:

• Maintain current knowledge basis of the organization's manufacturing process, system technology, current good manufacturing practices (cGMPs), relevant industry guidance, emerging draft guides (GxP), etc.

• Provide information/guidance or assistance/instruction with the initiation, authorship, completion and follow-up activities of department documentation and records. i.e. change control, investigation, root cause analysis, risk assessment, impact statement, corrective/prevention action plan, standard operating procedure/work instruction/job aid, periodic evaluation report, logbook, maintenance record/work order, lifecycle document, policies, etc.

• Perform periodic review/evaluation of documents for compliance with established quality/regulatory standards/requirements, policies/guidance, and procedures.

• Act as a liaison between Engineering & Automation and Quality/Regulatory to identify and address compliance related issues.

• Identify and support/lead initiatives for continuous improvements: comprehend current state, assist in cost benefit analysis, evaluate acceptability/appropriateness, coordinate resources and participate in execution.

• General Department Compliance - Author responses, and track/trend results of department quality/compliance and regulatory audits/inspections.

• Automation System Compliance -Author periodic evaluation reports for automated systems and coordinate system stakeholder review.

Knowledge, Skills, and Abilities:

• Strong Knowledge of cGMP biotech/pharma manufacturing operations/laboratory testing, regulatory and quality requirements/guidance, Root Cause Determination and Risk Management Techniques, procedures and documentation methods.

• Ability to manage multiple tasks and meet deadlines.

• Ability to speak to large groups (including senior management and regulatory agencies).

• Excellent writing, communication and interpersonal skills.

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to interpret data and develop improvement plan

• Initiating the development of leadership skills by providing training and guidance to others

• Anticipates and plans for change

• Critical thinking skills

• Demonstrates analytical skills through problem-solving

• Demonstrates leadership by being approachable

• Participates in projects in addition to daily responsibilities

Education and Experience:

• Compliance Specialist-Engineering & Automation: BA/BS required, preferably in an engineering or scientific related field, with 2+ years of relevant experience

• Senior Compliance Specialist-Engineering & Automation: BA/BS required, preferably in an engineering or scientific related field, with 5+ years of relevant experience

• Or equivalent combination of education and experience

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 agencies: 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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