Specialist, Planning & Scheduling (m/f/d)
- Own and coordinate deviation records, supporting timely investigations and effective CAPA implementation
- Support and monitor change control activities to ensure compliant and efficient implementation of process and system changes
- Create, maintain and improve Standard Operating Procedures (SOPs) and Good Manufacturing Process (GMP) documentation that support robust and inspection-ready operations
- Execute calibration, validation and qualification activities for equipment and systems in accordance with approved standards and procedures
- Investigate technical issues, perform root-cause analyses and help implement sustainable corrective actions
- Perform quality risk assessments to support sound decision-making and maintain a high level of compliance
- Partner with cross-functional stakeholders to support audits, inspections and ongoing readiness activities
- Contribute to improvement projects that enhance compliance, system performance and operational efficiency
- Support Environmental Health & Safety activities, including Management of Change, where applicable
Adaptability, Adaptability, Analytical Thinking, Business Administration, Business Continuity, Business Information Systems, Business Systems, Clinical Trials Operations, Cross-Functional Communications, Data Analysis, Detail-Oriented, Documentations, Driving Continuous Improvement, Financial Forecasting, GMP Compliance, Inbound Logistics, Inventory Control Management, Life Science, Logistics Management, Medical Supply Management, MRP Systems, Production Planning, Six Sigma, Stakeholder Communications, Stakeholder Engagement {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) Job Description: Your Profile:
- Bachelor's or Master's degree in Life Sciences, Engineering, Pharmacy, or a related field preferred-
- Several years of experience in a GMP-regulated pharmaceutical, biotechnology, or clinical manufacturing environment-
- Hands-on experience in deviation management, change control, CAPA management and SOP/documentation processes-
- Practical knowledge of calibration, validation and qualification activities for equipment and systems-
- Strong technical problem-solving skills with the ability to work independently and make sound decisions within established procedures-
- Solid understanding of GMP requirements and quality risk management principles-
- A collaborative mindset and the ability to work effectively across functions and with diverse stakeholders-
- Fluent in English, written and spoken; additional language skills are an advantage-
- A structured, reliable and detail-oriented working style with a continuous improvement mindset-
- Comfortable managing multiple priorities in a fast-paced and regulated environment-
- Experience with systems such as SAP, ProCal, eVal, DeltaV, Veeva Vault, MEDS, or eShop Floor is considered an advantage.
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
No Travel Required Flexible Work Arrangements:
Not Applicable Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
N/A Job Posting End Date:
07/30/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R407269
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