Senior Specialist Engineering (Onsite)

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

- 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:

Preferred Skills:

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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. Asa 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

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 factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco 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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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