Work for McNeil Healthcare, LLC. (a Johnson & Johnson Co.), a site under Consent Decree, Las Piedras, PR.Jobs / responsibilities as part of the Engineering Department Project Management Team;• Design of Change Controls for Capital Projects activities (new Manufacturing equipments, new and upgrades on existing cGMP Facilities / Utilities).• Identify needs/requirements/deliverables related to Capital Projects activities, including; Commissioning, Qualification and Validation deliverables and resources for execution, Regulatory Assessments, EH&S Requirements, Engineering Drawings.• Act as a liaison between Project Management Team and various departments (Mfg, QA, TS, EH&S, outside contractors) to assure the flow of communication between groups.• Follow up on assigned projects detail plans and schedules, and approval of packages to support Projects Change Controls activities.• Manage document life cycle activities in Electronic Document Management systems.• Leading and/or participating on Project Management Team meetings. Jobs / responsibilities as a Sr. Compliance Engineer for the Engineering Department; • Initiate and develop investigations of non-compliance reports (NC) and of Quality Systems in accordance with the Good Manufacturing Practices and company procedures (Root Cause Failure analysis, Fishbone Diagrams, 6M, 5 Whys).• Supports the Engineering Facilities/Utilities Areas in QA inspections/internal cGMP system audits.• Development and execution of Change Controls activities for equipment, facilities, and systems as required.• Change, improve and create SOPs to align with the applicable Quality Standard(s).• Supports the Consent Decree Work Plan activities as required.• Attend to Engineering Department meetings.

Work as an expert on production equipment and processes, including manufacturing equipment and process review for improvement potential using statistical data and reports analysis. Provide education to engineers and manufacturing personnel (GMPs, Process Validation, Problem Solving and Root Cause analysis with PDCA approach).Upgrade operational methods and technologies to guarantee production capacity.Interface with the design group to assist in developing a manufacturable product.Team with Manufacturing and QA personnel for review and disposition production defects (NCRs, CAPAs).Apply Six Sigma and Lean Tools to resolve or improve production problems.Prepare Capital Expenditure Requests as required for tool/equipment replacement.

Provide guidance to the Manufacturing & Utilities Engineers in terms of the most current validation practices and manufacturing tendencies in the industry (GMPs, 21 CFR Part 11/820, ISO 13485). Verifies that all documentation in validation protocol packages are evaluated and in compliance.Provide timely and efficient technical support in the development and/or revision of SOPs, FMEAs, Control Plans, Validation Projects and Change Controls activities for manufacturing equipments, facilities and automated systems.Establishment of the Site Facilities/Utilities Change Control Procedures.Formulate Action Plans for the resolution of manufacturing issues / problems / discrepancies / deviations and assist on the plans conclusion.Investigate and identify root causes and implementation of effective preventive / corrective actions (NCRs, CAPAs, Trendings).Write comprehensive technical reports to support investigation projects (Pilot Protocols, Engineering Samples).Project Lead for the Packaging Area Remediation Plan activities. Development and maintenance of Project Schedule (MP) and tasks assignments. Assure documentation compliance to specified procedures and regulations, documentation review / assessment (including SOPs, FMEA, 21 CFR Part 11 and CSV Assessment). Development/revision of SDLC documentation, including; Master Plan, PVP, FRS, FDS, TM, Risk Assessment documentation, IQ/OQ/PQ Protocols and Reports.

Snr. Software/CSV QA Engineer for the LifeScan One Touch Ultra Aguadilla New Plant Start Up. Work on the CSV Validation Master Plan to define the Software/CSV project validation strategy, CSV validation activities and project deliverables.Revise and approve of the System Development Life Cycle (SDLC) documentation (including FAT, SAT, Validation Plans, URS, FDS, TM, and IQ & OQ Protocols and Reports) applicable to all software/computer systems used to automate manufacturing process, computer system used to monitor and control the rooms environmental conditions (facilities) and the quality systems. Assure all documentation is in compliance to local procedures, industry standards and regulations (including GMPs, 21 CFR Part 11 / 820, ISO).Assure Start Up Project events and deliverables are reviewed and approved timely. Provide support to the Operations, Manufacturing, Engineering and Facilities Departments accordingly. Assure that solutions and deliverables involving quality elements are complete and compliant.