Sr. Spclst, Engineering

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

This Senior Engineer position will provide commissioning, qualification, and validation support as well as engineering support at the West Point site under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Primary responsibility will be to provide commissioning/qualification/validation support related to changes and new equipment purchases for areas within our Research & Development Division Clinical Supply. This will require routine interaction with business areas across the site such as Pharmaceutical Operations, PR&D, Global Clinical Supply (GCS), Analytical Research & Development and partner groups such as Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM). Provide commissioning, qualification, and validation support, ensuring facilities, utilities and equipment are qualified and are suitable for both GMP and developmental use. Author, execute and in some cases review/approve GMP documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities and computer systems. Prepare and approve qualification protocols and summary reports. Execute qualifications, commissioning and decommissioning activities. Prepare Validation plans and annual reports around critical equipment and systems. Maintain GMP documentation, where applicable. Facilitate and/or participate in Quality Notification (QN) reporting, investigations and any related corrective action/preventive action (CAPA). Support equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities. Interface with site engineering and maintenance groups, as well as outside vendor support. Support is inclusive of both ongoing operations and installation of new capital/facility improvements. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. #eligibleforERP PSCS

Requirements

Bachelor's degree in engineering or science plus a minimum of 5 years of related qualification/validation/engineering experience within the pharmaceutical industry.
Knowledge of commissioning, qualification/validation processes.
Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
Familiarity with Computerized Maintenance and Management Systems (CMMS).
Troubleshooting ability (mechanical/electrical/automation) and capital project (support).
Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.
Effective organizational skills.
Effective communication
Strong computer skills
Adaptability
Business Management
Capital Project Management
Change Management
Computer Control Systems
Data Analysis
Deviation Management
Environmental Policy
Environmental Research
Equipment Qualification
Facility Management
GMP Compliance
Good Manufacturing Practices (GMP)
Maintenance Management
Maintenance Supervision
Occupational Safety and Health
Periodic Reviews
Pharmaceutical Process Engineering
Process Control
Quality Management
Quality Management System Auditing
Regulatory Audits
Sterile Manufacturing
System Commissioning

Nice To Haves

Experience with process control computer systems (DeltaV, Ignition)
eVal - Paperless electronic validation system
Experience with SAP Plant Maintenance
Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).
Familiarity with Planning and Scheduling practices as well as business/financial practices.
The candidate should be able to work independently and lead or facilitate tasks successfully.

Responsibilities

Provide commissioning, qualification, and validation support, ensuring facilities, utilities and equipment are qualified and are suitable for both GMP and developmental use.
Author, execute and in some cases review/approve GMP documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities and computer systems.
Prepare and approve qualification protocols and summary reports.
Execute qualifications, commissioning and decommissioning activities.
Prepare Validation plans and annual reports around critical equipment and systems.
Maintain GMP documentation, where applicable.
Facilitate and/or participate in Quality Notification (QN) reporting, investigations and any related corrective action/preventive action (CAPA).
Support equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.
Interface with site engineering and maintenance groups, as well as outside vendor support.
Support is inclusive of both ongoing operations and installation of new capital/facility improvements.