Associate Director Engineering Pharmaceutical Technical Operations

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Overview: We are seeking an experienced Associate Director of Engineering to oversee technical operations within our sterile fill/finish manufacturing facility. This role emphasizes strong technical skillsets in sterile manufacturing, process development, and leads a team focused on optimizing production efficiencies while ensuring compliance with regulatory standards.

WHAT YOU WILL DO

Key Responsibilities:

• Technical Oversight: Lead, mentor, and coach the pharmaceutical technical operations (PTO) team in their technical support activities, including investigations, product and cleaning validations, compliance audits, process monitoring, and requalification. Provide leadership in driving resolution of complex investigations for deviations and customer complaints.
• Process Improvement: Drive continuous process improvement initiatives to enhance process robustness, cycle time reduction, cleaning efficiency, yield optimizations, alternate source qualifications etc. Able to utilize digital and statistical tools for proactive process analysis monitoring.
• Regulatory Compliance: Maintain a deep understanding of current regulatory guidance including EU Annex 1. Provide ongoing technical support during regulatory audits and ensure adherence to Quality Management System (QMS) topics pertinent to PTO operations.
• Team Leadership and Development: Manage a team of engineers by setting priorities and developing individual career development plans. Foster an inclusive work environment that emphasizes professional growth, collaboration, and technical excellence.
• Technical Expertise: Act as the subject matter expert (SME) for sterile fill-finish unit operations, process engineering and process design. Ensure successful implementation of new technologies and practices that enhance operational robustness and cost efficiency.
• Cross-Functional Collaboration: Work closely with cross-functional teams including Biotech Integrated Production Team (IPT) and other site groups, to align priorities, share best practices, and drive strategic initiatives aimed at business transformation and risk mitigation. Support strategic initiatives activities to enhance site performance metrics and provides expert knowledge to the site and across our company global technical network (while leveraging on other site experiences/ knowledge).
• Safety Leadership: Uphold and promote Environmental, Health & Safety (EHS) standards by participating in safety walks, process hazard analyses, and ensuring compliance throughout all operations.
• Documentation and Compliance: Oversee the writing and review of SOPs, gap analyses, and job aids to ensure compliance with corporate policies and guidelines.

WHAT YOU MUST HAVE

Ideal Candidate Profile:

• Proven experience in sterile fill/finish manufacturing and process development.
• Strong leadership skills with a demonstrated ability to coach and develop teams.
• Extensive knowledge of compliance standards and regulatory requirements in the pharmaceutical industry.
• Ability to leverage industry best practices to enhance operational processes.
• Proficiency in problem-solving and statistical analysis tools.

Qualification:

• Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences.

Experience:

• Minimum 8 years technical experience in related pharmaceutical manufacturing industry
• Minimum 2 years in supervisory position of professional staff and/ or demonstrated capability to successfully lead large teams in complex projects.
• Expert knowledge of core technology/unit operations relevant to Biotech and/or related Sterile manufacturing.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/10/2025

• 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.

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