Compliance Engineer

The Compliance Engineer, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers.  

• Ensure equipment and technologies employed at company remain in compliance with local, global and regulatory policies, procedures and guidelines.
• Receive and review revisions to USP, EP, JP, and FDA and regulatory guidelines. 
• Perform gap analysis on existing equipment and technologies to ensure compliance.
• Review new equipment and technologies as it comes to site to ensure compliance.
• Participate in revisions to departmental procedures to ensure compliance. 
• Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines.
• Support or lead HPR on-demand board meeting and HPR investigation/deviation.
• Through job functions listed above identify and scope projects of small and large complexity required to keep equipment or the department in compliance.
• Lead/Support projects both small and large in scope required to keep equipment or the department in compliance.
• Participate in and prepare for both internal and external audits. 
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
• Ability to sit, stand, walk, and move within workspace for extended periods.
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
• Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

Requirements

• BS in Engineering or Science related discipline preferred.
• Minimum 5 years’ experience in FDA-regulated industry.
• 2 years’ experience in a quality assurance related discipline preferred.
• In depth knowledge of regulatory guidelines such as FDA, EMA, USP, EP and JP.
• Excellent computer skills including knowledge of calibration management and environmental monitoring systems.
• Strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. 
• Strong attention to detail.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills.  Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Strong presentation development and delivery skills.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Ability to organize and present clearly.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.