MANUFACTURING PROCESS COMPLIANCE ENGINEER
You gained 3-4 years Process/Quality/Regulatory experience in GMP regulated industry.
You have good communication and listening skills and a strong critical thinking.
You are able to work on a strict time schedule, adherent to deadlines, following priorities changes, taking initiative and providing solutions to promote efficiency.
We are looking for a Manufacturing Process Compliance Engineer able to perform activities to ensure the Manufacturing organization regulatory compliance and ensure updates of the Process Characterization documentation. Provide scientific and technical information support in risk analysis. Ensure Manufacturing organization manage process changes following defined procedures. Actively participate to QMS improvement in order to guarantee manufacturing processes adherence. Have a strong commitment to quality assurance, and a willingness to support the quality first culture on the Site.
- Promote the Company’s Health, Safety and Environmental culture, transfers it into procedures and work instructions to discipline and monitor the team activities and keep a healthy and safe-conscious working environment, in order to minimize or eliminate risks exposure to personnel and respecting and ensuring the other people’s respect of security guidelines. Immediately advice the head of department of any risky task and work to make it solved. Contribute to the development and improvement of above cultures/procedures in cooperation with the EHS department and managers. Make sure that EHS experts are consulted throughout the projects in order to receive their approval for all new processes implemented.
- Actively participate to maintain accurately all Process Characterization documentation and databases. Assist Manufacturing in maintaining daily compliance to regulatory affairs. Facilitate and support Manufacturing in the revision and creation of processes, procedures, forms, etc. as necessary to maintain compliance and effectiveness of Quality Management System. Support the revision of validation/verification protocols for the new product/process development and changes to existing products/processes.
- Assist in maintaining organizational readiness for internal and external audits of the quality system; audit processes for compliance with internal procedures, record deficiencies and ensure Manufacturing corrective actions are developed and implemented. Facilitate Manufacturing address non-conformities from internal and external audits. Performs gap assessment, internal and external audits and may serve as a Lead Auditor.
- Partners with Manufacturing, QA Production Support and Validation team to ensure compliance of Manufactruing processes in an ever-changing regulatory environment. Collaborate with Process and Manufacturing engineers by actively participating in risk analysis, ensuring standardization between process steps. He/She is able to prepare/revise SOP’s, change control documentation, investigations, CAPA’s and training materials used by the Manufacturing team in the performance of their work
- Supports the responsible for regulatory oversight and all manufacturing documentation associated with our Reduced Risk Products (RRP). Having good knowledge of regulations and SOPs applicable to area of responsibility, assists with quality improvement initiatives as needed. Assists with development of SOPs or other quality documents as needed. Interface with the affiliates SME’s to ensure that applicable SOP’s are followed, and that the work performed by the team is documented and recorded properly.
- Have a strong commitment to quality assurance, and a willingness to support the quality first culture on the Site. Must be self-motivated, detail oriented and comfortable working in a dynamic team environment with minimal supervision. Thanks to the knowledge of Process Engineering and Quality Management Systems, trains employees on Manufacturing Process Compliance, demonstrating ability to train others
- She/He is able to analyze trend of routine manufacturing deviations to determine root cause and writes final investigatory report. Assists Manufacturing in the analysis and reporting of complex deviations. Assists in implementation of corrective actions. Writes and support Manufacturing team on change controls. Proposes and drafts changes to SOPs. Coordinates with Quality Assurance to ensure that incident/deviations, planned deviations, and change controls are closed in a timely manner. Review Process Changes supporting Manufacturing to act in compliance with procedures.
- Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills. She/He is also energetic and willing to help our company grow by building compliance programs and actively contributing to continuous improvement. Ability to conduct complex troubleshooting. Demonstrated initiative through past experience. Identify continuous improvement opportunities and lead efforts to improve processes, reduce waste and reduce cost. Provide regulatory guidance and support to project teams including standards requirements.
Education and professional desired experience
- University Degree in Engineering or Science field (Chemistry, Chemical Engineering, Industrial Chemistry, Pharmaceutical Technologies) or equivalent.
- 3-4 years’ Process/Quality/Regulatory experience in GMP regulated industry (Medical Device, Pharmaceutical, etc.).
- Excellent written and verbal communication skills in Italian and English. Ability to communicate effectively (up, down, and laterally, including technical and non-technical personnel) with others with strong communication skills.
- Strong critical thinking, time management and organizational skills.
- Demonstrated ability to multitask and consistently meet deadlines.
- Good math and computer skills and knowledge of Microsoft Office tools.
- Be independent and a team player at the same time.
WHAT WE OFFER
You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the Company.
We offer a permanent contract with competitive salary commensurate to the professional experience.
WHO WE ARE
PHILIP MORRIS MANUFACTURING & TECHNOLOGY BOLOGNA SPA (previously Intertaba) is a Philip Morris International affiliate since 1963 and Centre of excellence in innovation of production process technologies for cigarette filters, and in potentially reduced risk products.
Philip Morris International Inc. (PMI) is the leading international tobacco company, with six of the world’s top 15 international brands, including the number one cigarette brand worldwide. PMI’s products are sold in more than 180 markets. In 2014, the company held an estimated 15.6% share of the total international cigarette market outside of the U.S., or 28.6% excluding the People's Republic of China and the U.S. For more information, see http://www.pmi.com
Job ID IT-02368