Lead Operations Specialist

2 weeks ago

Rahway, New Jersey, United States MSD Malaysia Full time
Senior Operations Specialist - Facilities and Project Management
The West Point campus is a key manufacturing site for our company, focusing on vaccine production with a workforce exceeding 2000 employees.

This facility is dedicated to the production of both bulk and final dosage forms for our vaccine offerings and is expanding to meet future demands.

The Project team for the Live Virus Vaccine Filling Facility is looking for a highly skilled and motivated Senior Operations Specialist to join our efforts in managing the facilities and the new vaccine filling and lyophilization processes.

As a Senior Operations Specialist, your role will involve collaborating with various departments to facilitate facility management, commissioning, qualification, startup, and operational readiness activities. This position reports to the Operations Associate Director and requires exceptional leadership and project management capabilities.

Key Responsibilities:


Oversee Facility Transition and Compliance:
Manage the transition of the facility from commissioning and qualification to operational status, ensuring adherence to safety protocols, environmental standards, cGMPs, and SOPs. Work closely with cross-functional teams to maintain seamless operations and regulatory compliance.

Provide Comprehensive Facility Support:
Serve as the primary contact for facility-related inquiries and assist various departments. Proactively identify and resolve facility-related challenges to ensure uninterrupted operations.

Direct the SOP Program:
Establish and implement a thorough Standard Operating Procedures (SOP) program for the new manufacturing facility. Ensure all SOPs are current, precise, and compliant with industry regulations. Collaborate with experts to draft and review SOPs as necessary.

Manage Change Control Processes:
Lead change control initiatives related to facility operations, ensuring proper documentation, assessment, and execution of changes. Work with cross-functional teams to evaluate the impact of changes on operations and implement necessary adjustments.

Lead Projects for Facility Improvement:
Take charge of projects aimed at enhancing facility operations, efficiency, and productivity. Coordinate with stakeholders to establish project goals, develop plans, allocate resources, monitor progress, and ensure timely completion.

Ensure Compliance:
Conduct regular audits of facility operations to verify compliance with safety regulations, environmental standards, cGMPs, and SOPs. Identify opportunities for improvement and implement corrective measures as needed.

Qualifications:
Minimum of 5 years of relevant experience in the pharmaceutical, biotechnology, manufacturing, or related sectors.
Strong knowledge of facility design, commissioning, qualification, startup, and operational readiness processes.
Expertise in developing and implementing Standard Operating Procedures (SOPs) for manufacturing environments.
Demonstrated project management skills, with the ability to lead and prioritize multiple initiatives concurrently.
Excellent communication and interpersonal abilities, facilitating effective collaboration with cross-functional teams.
Detail-oriented with strong analytical and problem-solving skills.
Familiarity with regulatory requirements and compliance standards in the pharmaceutical industry.
Understanding of cGMPs and FDA regulations.
Bachelor's degree in engineering, life sciences, or a related discipline, or a High School Degree with relevant experience.

Preferred Skills:
Experience in facility startup, including equipment and process qualification/validation.
Facility management experience in a manufacturing/cGMP setting.
Knowledge of Lean Six Sigma or other continuous improvement methodologies.
Understanding of environmental health and safety practices.
Previous experience in a startup environment or supporting the launch of a new manufacturing facility.
Join our team and contribute to the success of our Drug Product Manufacturing Facility Startup. If you are a collaborative, detail-oriented professional with a passion for facilities management and project execution, we want to hear from you.

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