Calibrations Engineering Manager

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

We are seeking a Growth and Improvement minded Calibrations Engineering Manager that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Calibrations Engineering Manager is a leadership opportunity within the Engineering/Maintenance Team supporting our Millsboro animal health manufacturing operations. The individual in this role must provide direction, coaching, and technical expertise to Calibration and instrumentation technicians and actively manage the calibration team to reliably support customer demand (including employee development, routine coaching sessions, recognition, and performance management).

Additionally, the selected individual must become proficient in the use of manufacturing systems and knowledgeable of site procedures to resolve process/equipment issues, minimize downtime, and ensure product quality. You will actively support and embrace an ethical, respectful and inclusive team culture which may include providing Maintenance Management support in times of high demand or to maintain business continuity.

This role will require you to develop and foster a strong support network across all site departments including Safety, Maintenance & Engineering, Operations, Quality, IT, and other groups as required. This position may require occasional travel to support factory acceptance testing, training or best practice sharing.

Key Functions

Primary

• Serve as the Calibration Departmental Manager

• Provide data-based decision making and prioritization

• Ensure regulatory and corporate compliance | Foster an ethical, respectful, and inclusive team environment | Support a culture of transparency and Continuous Improvement

• Ensure effective communications including scheduling and attendance of routine team meetings

• Provide technical writing and collaboration support to mentor and develop subordinates

• Ensure operational priority with a focus on safety and compliance

• Serve as the site Calibration SME for site Quality Systems, Audits, Maint/Eng Projects, Safety and Validation

• Attend operational meetings to provide key input for process controls, determination of tolerances for critical CPPs | Attend Tier (1 & 2) meetings and maintain Departmental metrics

• Provide clear and logical prioritized Calibration goals | Foster an environment of teamwork and collaboration including regular feedback

• Ensure compliance to cGMP, 9 CFR, EU (VMD) and corporate initiatives for Quality Systems

• Serve as a subsystem site owner (SSSO) and as a subject matter expert (SME) for the ProCal (CCMS)

• Coordinate departmental priorities, oversee calibration contract services, and ensure adherence to corporate and site initiatives

• Seek knowledge of emerging calibration technologies to support CAPA and or continuous improvement

• Initiate SOP/PM/Calibration redlines and revisions

• Maintain Calibration Budget targets including team staffing, overtime and or equipment to ensure customer demand is met and opportunities for cost savings communicated

• May require performance of some subordinate duties or supplement site maintenance management to ensure Maintenance and Engineering department business continuity

• May provide support in Annual User Access Reviews relative to calibrations

• Provide the necessary investigational and or change control support using the Reliance (QMS)

• Support Quality Systems, site projects, safety, may travel to supplier locations to support Factory Acceptance Test (FAT)

Employee Development | People Management

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Hire, develop, motivate, and manage a team to ensure reliable calibration execution

• Assign yearly performance objectives and track metrics for the team in alignment with department and site goals

• Provide regular feedback and coaching to employees on work performance

• Provide leadership to the team as needed based on the team’s capabilities and maturity

• Ensure on time approval of payroll activities using site approved software like ADP

• Initiate SOP/PM/Calibration redlines and revisions

Communication

• Lead and support daily meetings to facilitate flow of information up/down through the organization

• Hold regular team meetings to cascade information and collect team feedback

• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise

Education

• Bachelor degree in Science, or Engineering

Experience | Skills | Knowlege

Required

• Five (5)+ years management experience in a USDA and or FDA regulated manufacturing maintenance and/or Engineering department

• Demonstrated ability to lead a team (i.e. experience leading directly as a supervisor/coach or indirectly as part of a project or through routine process execution)

• Ability to manage multiple priorities and coordinate people/resources to meet schedule

• Ability to prioritize, align and simply to focus on and obtain business results

• Principled and strong interpersonal, communication, organization and problem-solving skills

Preferred

• Previous management experience with Calibrations using ProCal in a cGMP-regulated manufacturing environment in either FDA or USDA regulated industries

• > 10 years Maintenance and/or troubleshooting experience with complex process and/or utility systems

• Experience using electronic manufacturing systems (e.g. CCMS, ERP, BMS, SAP, etc.)

• Experience in critical feedback and coaching, conflict resolution and performance management discussions

• ProCal certification

• Value stream mapping, A-3, Lean, Six Sigma, problem solving skills in Root cause investigational experience

• Previous training of individuals in complex manufacturing/work environments

• Experience with use of Safe Work Permits, LOTO, HECPs, Walk throughs, MOC

• Meeting Facilitation/Training/Presentation Skills

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

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.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Requisition ID:R226330