Matthew J. Sleeper Email & Phone Number

Hanover, Nj, Us

Cross-Functional Project and Technical Leadership - Site Lead/SME for Site Packaging Serialization Program, using Antares Vision - Led Packaging Serialization Launch for Ridgefield, NJ, and launch of ~40 serialized SKUs - Production Technical and End User Support for Packaging Operations, on/off hours - Provide system administration and maintenance support for integrated packaging lines - Escalate investigation of issues to vendor as neededOther - Automated Systems Validation and Support - Laboratory Systems Validation Support - Equipment Qualification, FAT/SAT, IQOQ and PQ/PV - Computer Systems Validation Projects, Work Leader - Quality System Leadership, gap to standards

Management of Computerized Systems Compliance Program- Gap to evolving standards and guidance- Create and manage all standard operating procedures- Create and manage training curriculum and training delivery- Manage periodic review schedule and lead reviews with business/system owners- Provide support for third-party audit inquires as needed- Provide input on change control scope, requirements and strategiesEnterprise Systems Validation Lead- Lead validation planning and execution around the software development life cycle (SAP, Empower, etc.)Data Integrity Lead for Computerized Systems- Manage remediation efforts for all validated computer systems, all impacted areas- Gap to standards and lead remediation of technical and procedural controls- Work with business/system owners and end users to establish compliance controls

Rahway, New Jersey, Us

Merck Manufacturing Division in Kenilworth, NJ (commercial manufacturing & packaging site), implementing Proactive Process Analysis and conducting Continuous Process Verification for Tablet Manufacturing operations.Commercial Packaging Technology – Responsible for addressing process and component issues. Walk through packaging lines on a regular basis to discuss any issues with operators, mechanics and supervisors. Escalate component issues to vendors. Research alternative replacement components for cost savings or substitution.Packaging Tech Transfer – Manage packaging technology transfer projects and product pre-launch activities. Transferred fourteen products comprising sixty-three individual product SKUs (Rx and Consumer), including blister and bottle presentations, inhalation devices, bulk vials, and women’s health products for secondary packaging.Packaging Development – Responsible for all aspects of packaging development studies, component machineability and engineering protocols, test new or modified third party components with commercial packaging equipment and/or data gathering in support of regulatory filings.Printed Component Support – Responsible for printed component change management, including CAD updates for design templates. Create new printed component design templates for use in artwork generation using vendor die lines.Non-Commercial Packaging Operations – Responsible for packaging of all non-commercial product samples to include blister, bottle, inhalation and LOC presentations.Process Improvement – Participate in Kaizen packaging process improvement events utilizing Six Sigma methodologies and commercial packaging walk-through activities.Packaging Sub-Team Leader – Lead Packaging Sub-Team projects for consumer healthcare packaging transfer projects and initiatives.Packaging Change Management – Responsible for driving material changes, printed component specifications and packaging transfers.

Rahway, New Jersey, Us

Responsible for the successful implementation of validated cGxP computerized systems used in support of commercial manufacturing and packaging, enterprise systems, laboratory systems and process control systems.Responsible for crafting validation and testing strategies following applicable regulatory, corporate and site-wide requirements for cGxP and Part 11 compliance.Responsible for leading Business, IT stakeholders and Project Teams through the validation life cycle to validation and quality compliance in accordance with applicable policies, procedures and regulatory guidance.Responsible for ownership of all system related computer validation documentation and representation to third parties (FDA, Lachman, internal, etc.) during Consent Decree.Responsible for change management strategies, documentation, oversight and compliance of deployed regulated systems.Responsible for training vendors and contractors on applicable site-wide procedures to conduct project work.Responsible for all related deviation investigations and reports, and related CAPA implementation. Responsible for authoring or revising computer validation related procedures and documentation templates.

Pennsauken, New Jersey, Us

Specializing in custom software development and project management for Fortune 500 client solutions.

Masters Of Science, Pharmaceutical Manufacturing

Graduate Certificate, Pharmaceutical Manufacturing

Bachelor'S Of Science, Business Administration