Merck & Company Inc
Job Description
This Engineer position will provide commissioning, qualification, and validation support as well as engineering support under the remit of Our Company’s Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The position is based at the West Point, PA site but may require routine travel to the Rahway, NJ site. Primary responsibility is to provide ongoing commissioning/qualification/validation related to changes and new equipment purchases within our Research & Development Division’s Clinical Supply. This requires routine interaction with business areas across the site such as Vaccine Process Research & Development, Global Clinical Supply, and Analytical Research & Development, as well as facilities/engineering partner groups such as Engineering, Maintenance, and Utilities (EMU), and Original Equipment Manufacturers (OEM). Responsibilities
Provide commissioning, qualification, and validation support, ensuring facilities, utilities and equipment are qualified for both GMP and developmental use. Author, execute and review/approve GMP documentation, emphasizing Qualification and Validation plans for 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. Facilitate and/or participate in Quality Notification (QN) reporting, investigations and 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 both ongoing operations and installation of new capital/facility improvements. Education
Bachelor’s Degree in Engineering or Science plus a minimum of 3 years of related qualification/validation experience. Required Experience and Skills
Knowledge of commissioning, qualification/validation processes including periodic review. Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures. Familiarity with Computerized Maintenance and Management Systems (CMMS). Troubleshooting ability (mechanical/electrical/automation). Ability to flexibly adapt to the flow of work across both Quality and Facility aspects to support the business. Effective organizational skills. Effective communication. Strong computer skills. Preferred Experience and Skills
Kneat – Paperless electronic validation system. Experience with SAP Plant Maintenance. Experience with ProCal as a Computerized Calibration Maintenance System (CCMS). Ability to work independently and lead or facilitate tasks successfully. Company Mission
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science,” great medicines can have a significant impact on 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. Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid model consisting of three total days on‑site per week, Monday – Thursday, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions where the work is performed at a Company site, or positions covered by a collective‑bargaining agreement, or those determined by the Company to require in‑person presence. Salary Range
The salary range for this role is $85,600.00 – $134,800.00. Benefits
We offer a comprehensive package of benefits, including medical, dental, vision, healthcare and other insurance benefits (for the employee and family), retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights ,
EEOC GINA Supplement . We are proud to be a company that embraces diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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This Engineer position will provide commissioning, qualification, and validation support as well as engineering support under the remit of Our Company’s Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The position is based at the West Point, PA site but may require routine travel to the Rahway, NJ site. Primary responsibility is to provide ongoing commissioning/qualification/validation related to changes and new equipment purchases within our Research & Development Division’s Clinical Supply. This requires routine interaction with business areas across the site such as Vaccine Process Research & Development, Global Clinical Supply, and Analytical Research & Development, as well as facilities/engineering partner groups such as Engineering, Maintenance, and Utilities (EMU), and Original Equipment Manufacturers (OEM). Responsibilities
Provide commissioning, qualification, and validation support, ensuring facilities, utilities and equipment are qualified for both GMP and developmental use. Author, execute and review/approve GMP documentation, emphasizing Qualification and Validation plans for 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. Facilitate and/or participate in Quality Notification (QN) reporting, investigations and 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 both ongoing operations and installation of new capital/facility improvements. Education
Bachelor’s Degree in Engineering or Science plus a minimum of 3 years of related qualification/validation experience. Required Experience and Skills
Knowledge of commissioning, qualification/validation processes including periodic review. Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures. Familiarity with Computerized Maintenance and Management Systems (CMMS). Troubleshooting ability (mechanical/electrical/automation). Ability to flexibly adapt to the flow of work across both Quality and Facility aspects to support the business. Effective organizational skills. Effective communication. Strong computer skills. Preferred Experience and Skills
Kneat – Paperless electronic validation system. Experience with SAP Plant Maintenance. Experience with ProCal as a Computerized Calibration Maintenance System (CCMS). Ability to work independently and lead or facilitate tasks successfully. Company Mission
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science,” great medicines can have a significant impact on 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. Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid model consisting of three total days on‑site per week, Monday – Thursday, with Friday designated as a remote‑working day, unless business critical tasks require an on‑site presence. This Hybrid work model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions where the work is performed at a Company site, or positions covered by a collective‑bargaining agreement, or those determined by the Company to require in‑person presence. Salary Range
The salary range for this role is $85,600.00 – $134,800.00. Benefits
We offer a comprehensive package of benefits, including medical, dental, vision, healthcare and other insurance benefits (for the employee and family), retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights ,
EEOC GINA Supplement . We are proud to be a company that embraces diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
#J-18808-Ljbffr