Merck · 1 day ago
Tech Ops Specialist – Change Control & Incoming Materials
Lansdale, PA
Full-time
Onsite
Entry, Mid Level
$87K/yr - $137K/yr
2+ years expMerck is a rapidly growing pharmaceutical manufacturer seeking a Tech Ops Specialist in Change Control & Incoming Materials. The role involves providing technical support for change management systems, leading continuous improvement projects, and ensuring compliance in manufacturing operations.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
No H1B
Responsibilities
Authoring and updating technical and manufacturing documents necessary for engineering studies, change control
Support and/or execution of continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies
Completing projects to improve the performance of our processes, including supporting investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right- First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times
Examination of an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause
Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale
Support of regulatory inspection activities for the facility
Providing on-the-floor support of operational and technical (process/equipment) issues on the shop floor, including GEMBAs, and/or troubleshooting initiatives
Supporting team safety, environmental, and compliance objectives
Managing project and support investigation timelines as needed to ensure key compliance and customer due dates are met; escalating any potential delays and developing remediation plans when possible
Collaborating effectively with the area leads, Operators/Mechanics, support groups, Quality, and Planning
Qualification
Required
Bachelor's Degree or higher (Engineering or Sciences, preferred)
Two (2) years post-bachelor's degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories
Experience in change control and/or equipment support and/or project support role
Highly developed communication, leadership and teamwork skills
Ability to manage projects/work to schedule/deadlines
cGMP Compliance
Change Control Processes
Data Analysis
Detail-Oriented
GMP Compliance
Investigation Management
Manufacturing
Manufacturing Support
Process Improvements
Regulatory Inspections
Vendor Management
Preferred
Experience in biologics, vaccine, or bulk sterile manufacturing facilities
Change Control author
Vendor Change Notification experience
Deviation Management
Experience working with Suppliers
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-02-12
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