Senior Specialist Engineering (Onsite)

MSD; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision plans

401(k) retirement benefits

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Process Supervisor to oversee small-scale organics operations in a GMP environment. You will help ensure facility readiness for API processing, manage daily activities, and drive improvements with cross-functional teams.

The role requires 5+ years in process development or pilot plant settings, strong leadership, and hands-on experience with pilot-scale equipment. 8-hour shifts rotate 1st/2nd week, onsite five days a week.

Qualifications

• Bachelor's degree in Chemical Engineering or related field with 5+ years in process development lab or pilot plant.
• Supervisory experience leading shop floor personnel in an operations setting.
• Solid knowledge of cGMP, GDP and Safety & Environmental regulations.

Responsibilities

• Ensure processes run within facility capability and safety constraints.
• Supervise or perform batch processes as needed.
• Maintain equipment readiness and manage cleaning, inventory and documentation.
• Write, issue, and review GMP documentation.
• Drive CAPA and continuous improvement projects across the building.

Skills

Chemical Engineering

Leadership

GMP GDP S&E compliance

Pilot/scale equipment

Process development

Root cause analysis

Safety awareness

Lean Six Sigma (preferred)

Education

Bachelor's degree in Chemical Engineering or related field

Associate's degree + 8+ years experience

High school diploma + 10+ years experience

Tools

Equipment Qualification

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.

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.

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
• Associates degree with at least 8 years of relevant experience in a process development lab or pilot plant/manufacturing facility
• 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

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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 Information

• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Not Applicable
• Shift: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): At times will work with hazardous materials

Salary Range

$117,000.00 - $184,200.00

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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: EEOC Know Your Rights EEOC GINA Supplement.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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