Senior Specialist Engineering (Onsite)

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co. in Rahway, NJ is seeking a qualified SSO Process Supervisor to oversee daily GMP production in the Small Scale Organics pilot plant, ensure safety and environmental compliance, and drive process improvements for API processing.

The role involves supervising operations staff, writing GMP docs, and collaborating with cross-functional teams to meet SSO objectives and customer requirements. Onsite five days a week with potential overtime.

Qualifications

• Bachelor’s degree with 5+ years in a process development lab or pilot plant/manufacturing facility.
• Experience supervising shop floor personnel in operations.
• Experience with cGMPs, GDPs, and Safety & Environmental regulations.
• Experience operating pilot or manufacturing-scale equipment.
• Strong communication and collaboration skills.
• Ability to perform root-cause analyses and avoid recurrence.

Responsibilities

• Run processes within the facility’s capability constraints.
• Execute batch processes in hands-on or supervisory roles.
• Ensure equipment readiness and maintain housekeeping and inventory.
• Write, issue, and review GMP documentation.
• Contribute to incident root cause analyses and CAPA items.
• Drive improvement projects and process setups.
• Provide constructive feedback to foster continuous improvement.
• Collaborate with building staff to share best practices.
• Investigate problems and SORs to resolve issues quickly.
• Understand hazardous work and issue necessary permits.
• Identify opportunities to improve efficiency, compliance, and safety.
• Support training, mentoring, and coaching of staff.

Skills

Chemical Engineering

Collaborative Leadership

GMP Knowledge

Process Control

Safety Compliance

Equipment Qualification

Technical Leadership

Root Cause Analysis

Lean Six Sigma

Team Supervision

Education

Bachelor's degree in Chemical Engineering or related field

Associate degree with 8+ years of relevant experience

High school diploma with 10+ years of relevant experience

Job description

Job Description

The Small Scale Organics (SSO) Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization, which enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites.

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The SSO Process Supervisor assists on daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements in addition to the existing labor contract to meet SSO objectives and customer requirements. The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements. This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and cross-functional SSO partners to drive overall success and performance of the building. This role will also be responsible for the prioritization and assignment of daily activities for the operations staff.

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Responsibilities:

• Ensure processes are run within the capability constraints of the facility.
• Execute batch processes as needed from either a hands-on role or a supervisory role.
• Ensure facility equipment readiness with respect to repair, cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.
• Write, issue, and review GMP documentation.
• Provide input for incident root cause analysis, reporting, and action items.
• Facilitate and drive building improvement projects and CAPA (Corrective Action and Preventive Action) completions.
• Provide input on and proficiently execute process setups.
• Provide regular feedback (both constructive and positive) to peers to promote a continuous improvement mindset.
• Collaborate with all building staff to share and align on best practices.
• Actively investigate problem statements and SORs (Safety Observation Reports) to promote fast and efficient problem resolution.
• Understand hazardous/high risk-work and issue permits as needed.
• Identify opportunities to improve building efficiency, compliance, and safety.
• Support training, mentoring, and coaching of operations staff.

Education Minimum Requirement:

• Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 5 years of relevant experience in a process development lab or pilot plant/manufacturing facility
• OR- Associates degree with at least 8 years of relevant experience in a process development lab or pilot plant/manufacturing facility
• OR- High school diploma with at least 10 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

Required Experience and Skills:

• Mechanical aptitude and familiarity with chemical process development and process equipment.
• Experience supervising a team of shop floor personnel in an operations environment.-
• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.
• Experience operating/maintaining pilot scale or manufacturing scale equipment
• Effective communication skills and a collaborative mindset.
• Experience in conflict resolution and root cause analyses.
• Ability to build effective work relationships with a strong workforce.
• Adaptable to a dynamic production environment.
• Relevant experience in a process development lab or pilot plant/manufacturing facility.
• This role requires working on 8-hour shifts that rotate between 1st and 2nd shift on alternating weeks throughout the year. Onsite presence is required five days a week. Occasional overtime work may be required based on business needs.

Preferred Experience and Skills:

• Lean Six Sigma Training / Certification.
• Experience with small molecule drug substance and/or biologics process development.

Required Skills: Chemical Engineering, Collaborative Leadership, Competency Management, Efficiency Improvements, Employee Training, Equipment Qualification, Good Manufacturing Practices (GMP), Industrial Processes, Manufacturing, Operations Support, Process Control, Process Hazard Analysis (PHA), Process Optimization, Safety Compliance, Technical Leadership

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is $117,000.00 - $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several