Project Engineer (Millsboro, DE) Job

Project Engineer (Millsboro, DE)-MAI000611

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Merck Animal Health, Millsboro, DE is a BioTechnology Center of Excellence that performs vaccine production operations from antigen production through formulation, filling and packaging. With expertise in mammalian, insect and avian cell culture production, live bird vaccine production, embryonated egg vaccine production, roller bottle vaccine production, bioreactor vaccine production and down-stream processing (water in oil emulsions, aseptic filling, lyophilization, etc.), the Millsboro site supplies and supports products for a wide range of species including poultry, equine, swine, bovine and companion animal.

The Project Engineer, provides support and expertise to site based manufacturing of USDA and VMD veterinary biologics, collaborates with Regulatory Affairs, Quality, EHS (Safety), GES (Global Engineering), BTS (Bio-Technical Support), IT and ATS (Analytical Technical Support) to ensure site systems, processes and projects meet or exceed regulatory and company standards. The Project Engineer will collaborate with site leadership on equipment and facility standards and/ or solutions that lead to stable and effective systems. They will direct on-site project teams, as well as supporting contractors, to ensure projects, are delivered on-time and on budget.. The Project Engineer shall be a highly motivated individual with a broad background and skill set to support the capital expansion of production processes and utility infrastructure at our Millsboro Manufacturing Facilities. We are seeking a self-motivated, independent engineer with strong analytical and problem solving skills and the successful candidate will have an attention to detail, be quality and customer focused, and have excellent written and oral communication skills.

Major Activities and Responsibilities:

- Manages internal plant capital projects as assigned, including scope development, estimating, budget, scheduling, change-control and project management of design, construction, commissioning and validation support.

- Manages contractors as required, including construction trades, calibration and maintenance.

- Understands customer (Internal & External) needs to effectively tailor project deliverables to meet user requirements.

- Supports and maintains project records to ensure strategic improvement decisions are considered.

- Relays best practices to various corporate and site groups ensure equipment performance and reliability..

- Ensures capital expansion and maintenance projects and controls meet quality and regulatory requirements.

- Ensure proper safety procedures, standard operation procedures and maintenance techniques are followed.

- Provides technical support to Production and other site departments as needed for troubleshooting, repairs and process optimization.

- Develops and maintains Maintenance SOP's, including preventive maintenance and calibration.

- Maintains facility design and engineering documentation including proper change management techniques.

- For technical projects, the incumbent will assist with the development of validation protocols thus requiring knowledge of validation, engineering, and/or the physical sciences.

- Provides basic technical support to staff groups on matters relating to the construction, commissioning and validation of equipment and processes for manufacturing operations.

- The incumbent is expected to collect and interpret information, develop and implement solutions to a range of projects and support activities.

- Provides leadership for troubleshooting and efficiently resolving manufacturing problems. Effectively develops and implements corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply of vaccine products.

- Upon receipt of assignment, works independently in the coordination and execution of assigned projects. Maintains active dialogue with project team members and keeps management well informed of project progress.

- Reviews literature and attends training sessions in order to develop and maintain a high level of expertise in engineering and related science fields.

- Supports all quality and safety initiatives.

- Helps to foster empowered teams to achieve site mission, vision and goals through: Efficient and safe operation of process systems, compliance with current Good Manufacturing Practices and production of product that is safe and efficacious.

- This position requires varying environmental conditions, such as: indoor/outdoor work,varying temperatures along with secondary gowning, entering coolers and freezers. Personal Protection Equipment (PPE) is required per Safety Policy. Examples of required PPE are: safety glasses, and safety shoes.

Qualifications

Education:

- Bachelor's degree in Engineering is required
Required:

- A minimum of 5 years’ industry experience as an engineer, in an engineering department that supports execution of capital projects in an active manufacturing setting.

- Proven project management, and coaching skills.

- Demonstrated ability to make rapid, disciplined decisions and solve complex problems

- Excellent communication skills, and must be able to lead in a team-based empowered culture.

- Working knowledge of industrial utilities used in a pharmaceutical regulated environment such as HVAC, HEPA Filtration, Electrical, Plant Steam, Clean Steam, Chilled Water, Water for Injection, Deionized Water, Compressed Air, Process gas, Waste treatment, etc.

- Working knowledge of complex building management and automation systems (Siemens, Johnson Controls, Delta V, PLCs, etc)

- Experience with regulations and codes associated with refrigeration, waste treatment, electrical, boilers, pressure vessels, etc.

- Experienced with a Computerized Maintenance Management System (CMMS), preferably SAP Plant Maintenance

- Proficiency in computer systems and applications (Examples: AutoCad, Microsoft Project, Microsoft Excel, Word, SAP Procurement)

- Ability to work independently and effectively with peers; display strong interpersonal and organizational skills.

- Experience with scheduling, organizing and supervising complex capital projects

- Working knowledge of regulatory requirements in accordance with manufacturing operations.

- Working knowledge and experience in Quality Management System (Change Control, Deviations, Investigations, Qualification, Validation, IQ/OQ/PQ, etc.)
Preferred :

- Professional Engineers (PE) license

- Project Management Professional (PMP) certification

- Working knowledge of Bioprocessing equipment such as Lyophilizers, Bioreactors, Fermenters, Centrifuges, UF Skids, Process tanks, CIP/SIP, Laboratory washers, Autoclaves, vial filling machines, High speed secondary packaging equipment, etc.

- OSHA 30HR

- Working knowledge of Regulatory requirements in accordance with cGMP and/or USDA manufacturing operations, OSHA, EPA, NFPA and DNREC

- Proven ability to use scientific problem solving and lean manufacturing principles (Examples Include: Total Productive Maintenance, Hoshin, 5S, Fishbone, Kata) to solve complex issues.

- Working experience with the USDA and EU (VMD) or FDA audits

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Maintenance/Utilities

Job Title:Sr. Spclst, Engineering

Primary Location: NA-US-DE-Millsboro

Employee Status: Regular

Travel: Yes, 20 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Yes Formaldehyde, BSL3 materials, Potassium Dichromate

Company Trade Name:Merck