Valeant Pharmaceuticals Engineer I, Quality in Wilmington, Massachusetts
Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
To provide specific, yet flexible, Quality Engineering expertise in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance of existing operations.
Participate in and provide quality support in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices.
Lead and work with teams to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
Recommend, plan and lead corrective and preventive actions for continuous improvements including investigations and root cause analysis.
Generate quality reports, evaluate and trend quality data, and propose solutions to drive process improvements.
Drive and monitor change management process to ensure thorough completion of all changes resulting in timely closure of change requests.
Reviews and approves validation protocols, reports, and data related to software, equipment, process, and product validations.
Provide guidance in the proper application of statistical analysis and scientific design of all verification and validation test documentation.
Responsible for the Site Validation Master Plan.
Perform revalidation and risk assessments to support the site validation master plan.
- Participate in or lead cross-functional project teams in identifiying and executing programs/tactics to improve existing operations with respect to quality, cost, and delivery.
General Quality Support:
Facilitate risk management activities including creating and maintaining risk plans, reports, and failure mode analyses for multiple product lines.
Create, revise and approve documents as required by changes to policies or in response to compliance issues ensuring adherence to regulatory, regional and internal requirements.
Plan and execute internal audits at the site against applicable Quality System standards/regulations and internal requirements.
Review and approve nonconforming reports and CAPA plans.
No direct reports.
Functions independently with minimal direction and as part of a team at the Wilmington Manufacturing site.
This position must be able to liaison with several internal functional areas including Manufacturing, Engineering, Facilities, Quality Control, Customer Fulfillment, and Purchasing.
Effectively interact with external auditors, suppliers, customers and all other employees including corporate officers.
Bachelor’s degree or equivalent in science or engineering.
Minimum of 4 years of cGMP experience in the pharmaceutical or medical device industry. Strong understanding and application of the Quality System Regulations (QSR – CFR 820) and ISO 13485/ISO9001 requirements.
Competency in Process Validation (IQ/OQ/PQ), Statistical Process Control and Capability Analysis.
Prior experience working in a Quality/Compliance, Validation, Engineering or technical role within the pharmaceutical or medical device industry.
Working knowledge of the requirements of FDA QSR CFR 820, ISO 13485 and ISO 9001. Work and problem-solve independently and as part of a team.
Excellent time management skills, work ethic and be proactive.
Excellent oral and written communication skills.
Must be able to write clear, concise and grammatically correct technical cGMP documents.
Proficient in Microsoft Office applications.
Lean Manufacturing / Six Sigma experience preferable.
Valeant is an EEO/AA employer M/F/D/V.
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Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
Job ID 8913
Category R&D - Other
Pos. Type Full Time