Merck

The Director, Process Engineering, in Global Engineering Solutions (GES) will be the primary Subject Matter Expert (SME) for core Sterile Drug Product (DP) Processing Unit Operations to supervise project implementation activities ranging from business case, design development, and implementation of the business solution.. Reporting to a GES Technology Director for Large Molecules, the Director is accountable for a portfolio of successful capital investments supporting DP manufacturing across the Biologics, Vaccines, and Animal Health Networks.. Minimum 12 years Pharmaceutical/Biotech industry in engineering, technology and/or manufacturing in biologics or vaccines, with minimum 8 years in Process Engineering in Sterile DP space.. Advanced understanding of isolated filling and lyophilization unit design & operations, including hygienic, CIP, SIP design and operations familiarity.. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

director process engineering

Job Description The Director, Process Engineering, in Global Engineering Solutions (GES) will be the primary Subject Matter Expert (SME) for core Sterile Drug Product (DP) Processing Unit Operations to supervise project implementation activities ranging from business case, design development, and implementation of the business solution. Reporting to a GES Technology Director for Large Molecules, the Director is accountable for a portfolio of successful capital investments supporting DP manufacturing across the Biologics, Vaccines, and Animal Health Networks. The Director will hold a senior position on the technical development career pathway and, as an individual contributor, will foster collaboration with other Integrated Project Team members, plant operations personnel, equipment vendors, and outside contractors. The Director provides deeps technical expertise and coaching to support capital project scope development and execution across the global portfolio, leads oversight and management of strategic OEM vendor partners supplying process equipment (including Filling Lines, Isolators, and Lyos), and supports internal and external DP manufacturing with SME inputs for escalations, critical operations, & tech transfers. The Director is expected to have an advanced knowledge of Industry approaches, ranges of technology solutions, Internal & External Guidance, and Standard Work related to Sterile DP Areas. The director is expected to provide technical coaching to help develop individuals within their influence by broadening their technical knowledge in their respective area(s) of expertise. Key Responsibilities <ul><li>Oversees a significant capital project portfolio of Sterile DP technical scope including Filling Lines, Isolators, and Lyos.</li><ul><li>Leads the prelim development of project scope, front-end planning, assuring viability of technology designs in proposed configuration, and evaluation of alternative solutions.</li><li>Coaches Capital Project Engineering teams on individual projects in technical aspects of their work assignments and their technical development.</li><li>Provides technical expertise to business studies, peer projects, and periodic operations investigations. </li></ul></ul><ul><li>Manages Key Partnerships with Strategic Equipment Vendors.</li><ul><li>Set strategies, implements standard approaches, plans future workloads, facilitates collaboration across the portfolio.</li><li>Monitors and appraises the work of partners in the preparation of project related deliverables. </li><li>Address escalations with the partner to expediently resolve issues across the portfolio. </li></ul></ul><ul><li>Serves as a Subject Matter Expert for core Sterile DP unit operations and facilities.</li><ul><li>Develops close working relationships and liaises other technical functions such as Quality, Operations, Technology, Safety, etc., to ensure successful technology transfer of new and inline products.</li><li>Participates in the development and review of engineering guidelines, standards, and policies related to Sterile DP Manufacturing. </li></ul></ul>Education <ul><li>Bachelor of Science degree (or higher) in Engineering or applicable Science </li></ul>Knowledge & Experience <ul><li>Minimum 12 years Pharmaceutical/Biotech industry in engineering, technology and/or manufacturing in biologics or vaccines, with minimum 8 years in Process Engineering in Sterile DP space.</li><li>Advanced understanding of isolated filling and lyophilization unit design & operations, including hygienic, CIP, SIP design and operations familiarity.</li><li>Experience with equipment life cycle approach and Capital Management stage gate process.</li><li>Demonstrate advanced leadership, interpersonal, teamwork & communication skills. Ability to get results in a cross functional environment and effectively influence partners.</li><li>Project Management Skills to facilitate teams in a matrix organization.</li><li>Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and equipment troubleshooting including experience implementing Lean methods and assessments. </li></ul>Base location for this role is flexible with our Company Sterile DP Network and will require significant Travel (>50%) to actively participate in Vendor Management and Design, FAT, & startup activities at Vendor Workshops and Project Site locations. 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. Current Employees apply HERE Current Contingent Workers apply HERE 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. Please click here if you need an accommodation during the application or hiring process. About We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination 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. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Salary Range $164,800.00 - $259,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed 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: No relocation VISA Sponsorship No Travel Requirements 50% Flexible Work Arrangements Hybrid Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a Requisition ID:R281888

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