-
Specialist, Operations
2 weeks ago
Merck & Company, Inc. Lansdale, United StatesThe Manufacturing Operations Specialist is assigned to a product manufacturing team and partners with the Operations Managers in coordinating maintenance activities and ensure the manufacturing area is operating at peak efficiency. Primary Responsibi Operations, Operations Manage ...
-
Specialist, Operations
17 hours ago
Merck & Company, Inc. Lansdale, United StatesThe West Point, PA campus is our Companys largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands Operations, Operations Manager ...
-
Regulatory Operations Specialists
17 hours ago
AA2IT Lansdale, United StatesSomeone working as labeling assistant, label coordinator, label design will be a good fit. Do not submit clinical packaging experience. · Manager would like to see candidates with label experience. · Preparing shipment of labels. · Checking quality of labels. · Printing label ...
-
Specialist, Clinical Operations
2 weeks ago
Merck North Wales, United States**Job Description** · **Position Description:** · **Specialist, Clinical Operations** · Global Clinical Trial Operations (GCTO) is a global organization operating in over 50 countries and is responsible in the delivery of our company's diverse development portfolio comprising ove ...
-
Clinical Operations Specialist
3 weeks ago
Collabera West Point, United StatesJob Description · Job DescriptionQualifications: · Title: Operations Planner-II · Education: High School/Associate degree/Bachelor's degree/Master's degree. · Work Experience Requirements: · • 3-5 years' experience in the pharmaceutical industry and/or clinical supply knowled ...
-
Specialist for Pool Operations
1 week ago
FusionTech Freemansburg, United StatesTo support our team, we are looking for a specialist for pool operations (m/f/d) in full-time, part-time, and mini-job basis at the earliest possible date in Freemansburg. · Your tasks · Supervision and care of year-round pool operations · Knowledge of pool technology · Care of ...
-
Clinical Operations Specialist
2 weeks ago
Innova Solutions Lansdale, United StatesJob Description: Responsible for independently coordinating all activities associated with timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as ...
-
Operations Specialist 2nd shift
1 week ago
Merck & Company, Inc. Lansdale, United StatesACCOUNTABILITY - Ensure that short term and long term objectives are achieved while reliably supplying quality product at a competitive cost consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manuf Operations Specialist, Operat ...
-
Associate Specialist, Operations Compliance
3 weeks ago
Merck & Company, Inc. Lansdale, United StatesPartner with the Operations Compliance Lead to facilitate compliance activities, audits/inspections, and process optimization. Work closely with subject matter experts and clinical supply operations staff to serve as a liaison between Global Clinical Operations, Compliance, Assoc ...
-
Operations Specialist
3 days ago
Univest Financial Corporation Souderton, United StatesAn Operations Specialist to join our growing Souderton, PA team. Please note: this is a fully in person role. Responsibilities Responsible for processing new accounts to the firm, related transactions and subsequent business. This will include, but n Operations Specialist, Operat ...
-
Operations Specialist
1 week ago
PNC Bank Corp. Horsham, United StatesExecutes complex transactions/processes utilizing standard procedures. May have specific responsibility for one or multiple specialized products or functional areas. Reconciles complex transactions of high risk and financial value in accordance with Operations Specialist, Operati ...
-
Operations Specialist
6 days ago
Univest Financial Corporation Souderton, United States· *All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected s ...
-
Operations Specialist
5 days ago
Univest Financial Corporation Souderton, United States· *All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected s ...
-
Senior Specialist, Quality Operations
2 weeks ago
Merck & Company, Inc. Lansdale, United StatesOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnerin Operations, Specialist, Quali ...
-
Operations Specialist
3 days ago
Univest Souderton, United StatesOverview At Girard we invest in the success of our employees and customers. We offer our employees the ability to be their authentic selves, while fostering a culture and an environment that inspires change and inclusivity. Seeking career-focused individuals, looking to bring pas ...
-
Operations Specialist
5 days ago
Grip Philadelphia, United StatesThe Operations Specialist is responsible for overseeing the daily operations of the warehouse, ensuring a smooth process from receiving to picking, packing, and shipping orders. This role guarantees that all orders are fulfilled accurately and on time while maintaining high stand ...
-
Specialist, Operations 2nd Shift Weekend
2 weeks ago
Merck & Company, Inc. Lansdale, United StatesThe Specialist, Operations supports manufacturing operations in the Vaccines HPV Bulk IPT organization. This high impact role in our Company assures that products manufactured comply with current Good Manufacturing Practice (cGMPs), operating procedu Operations, Continuous Improv ...
-
Operations Specialist I
4 weeks ago
Aon Fort Washington, United StatesAon is looking for an Operations Specialist I. · The Operations Specialist will support the Aon Affinity Life and Health Program in our Fort Washington, PA office. This position requires you to be in the office 50% of the time. · Responsibilities include processing endorsements ...
-
Operations Support Specialist
1 week ago
Aon Fort Washington, United StatesOperations Support Specialist · Exciting opportunity for a Support Specialist to join our team in Fort Washington, PA. This role is a part of our operations team and supports the Aon Healthcare underwriting team. · In this support role you will interact with internal associates a ...
-
Stellar Innovations Marlton, United StatesMAKE THE MOST OF YOURSELF · As a specialist warehouse operator (m/f/d) in Marlton, you will ensure smooth processes from goods receipt to storage, picking and shipping. In the warehouse, you will know exactly where and in what quantity goods can be safely stored and/or delivered. ...
Technical Operations Specialist - Lansdale, United States - Merck & Co., Inc.
Description
Summary:
The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the contracted person will work as an individual contributor, may act as a team or project lead and lead work of others as required, as well as contribute to the performance and results of a department. Additionally, this individual will provide technical guidance and anticipate and interpret needs to identify and implement solutions.
Qualifications:
Education Minimum Requirement:
• Bachelor's Degree in Engineering or Science
Required Experience and Skills:
• Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role.
• Minimum of six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations to vaccine manufacturing.
Preferred Experience and Skills:
• Strong understanding of Change Control and Project management
• Demonstrated ability to work both independently and as a part of a team
• Strong technical problem-solving abilities
• Demonstrated effective written and verbal communication skills
• Strong collaboration skills
• Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment
• Experience with introduction of process changes to a licensed process
Additional responsibilities include:
• Establish and manage project schedules and timelines
• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
• Responsible for stakeholder engagement, communication, and risk escalation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
• Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation.
• Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Consistent application of standardized work, engineering, and process tools (i.e. TrackWise, IPI, MS Project, Excel).
• Provide technical support to manufacturing for problems and issues.
• Work as a team member on complete manufacturing investigations, process improvement and/or validation projects.