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$142k–$224k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Healthcare, 401(k), Paid Holidays, Vacation
Posted 44d ago
Apply by Jul 10
~40 hrs/week
Responsibilities
Responsible for the maintenance, reliability, and calibration of utilities and process equipment within a biotech manufacturing facility. Leads tactical and strategic initiatives to improve reliability, ensure safety, and maintain regulatory compliance.
Requirements
Requires a Bachelor's degree in Engineering or Science with at least 8 years of experience in regulated industries like pharma or biotech. Must have working knowledge of cGMP manufacturing operations and experience with regulatory audits.
Full job description
Job Description
Our Engineers support complex manufacturing operations to ensure they are reliably executed and continuously improved. 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.
The Associate Director, Engineering is responsible for the maintenance and reliability of both utilities and process equipment. The scope of responsibilities includes maintenance and calibration, management of spare parts, and facility services for the facility. This role is responsible to lead the tactical and strategic initiatives that will drive reliability improvements. In addition, this role provides leadership that ensures a safe work environment with optimized product quality and manufacturing processes and regulatory compliance.
The facility consists of biotech operations including end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, and product inspection.
Primary Responsibilities:
Provides leadership and direction through individual contributors in the team, including contractors and full time employees.
Develops team strategy, including reliability plan, routine maintenance and improvement work, and executes to functional business plans.
Prioritizes based on compliance, reliability, departmental budget and production plan to address resource and operational challenges.
Leverages relationships with key clients and/or customers to support business needs.
Coaches/mentors direct reports responsible for their area.
Ensure proper team capabilities with appropriate trainings.
Manage the area succession plan across diverse skillsets for roles within team.
Partner across the facility leadership team and cross-functional teams (local and global) including for the startup and design of plant engineering, reliability, and maintenance programs for the facility.
Team responsibilities for improvement and maintenance projects may include change control and equipment qualification, obtaining bids, reviewing contracts, supervising, and providing follows-up on contract work within team’s scope, including the auditing of time and material reports for their area.
Responsible for assisting with master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP cleaning coordination for all facility shutdowns.
Responsible for regular maintenance shutdowns including project leadership and meeting facilitation.
Responsible for the preventive maintenance and calibration programs of all production equipment.
Daily support of all production equipment to ensure area safety, compliance, and production goals are met.
Spare parts risk-based assessments and identification of new parts to replace obsolescent parts to ensure correct type and number of spare parts are available for all production equipment.
Establishes processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities.
Manages equipment location and status in SAP as well as related equipment drawings.
Assists in deviation investigations for maintenance instruments, equipment, and systems.
Collaborates/Executes with the reliability engineers periodic reliability-based asset management assessments and owns area specific reliability actions.
Collaborates with production and automation for maintenance and troubleshooting equipment.
Collaborates with equipment vendors.
Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders with an emphasis on reducing reactive work and increasing reliability.
Maintains the integrity of equipment identification and specification data within the computerized calibration and maintenance management system.
Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures.
Monitor KPIs (MTTR, MTBF, Uptime) and ensure its accuracy in measuring key metrics.
Interacts and leads discussions within scope of work with representatives from regulatory agencies and external supplier.
Education Minimum Requirement:
Bachelor’s Degree in Engineering, Science or related technical field
Required Experience and Skills:
Minimum 8 years Maintenance or Engineering experience in regulated industries such as pharma, biotech, aerospace, cGMP operations (6 Years with a master’s degree or MBA: 4 years with a PhD), or military service combined experience:
Working knowledge regulatory requirements in accordance with cGMP manufacturing operations and demonstrated experience of interacting with site, divisional or regulatory audits/inspections.
Preferred Experience and Skills:
Working Knowledge of cGMP for pharmaceutical, Sterile and/or Biologics manufacturing
SAP experience related to plant maintenance and spare parts procurement systems
Reliability engineering experience
Good oral and written communication skills
Project management, including change control and equipment qualification experience
Required Skills:
API Manufacturing, API Manufacturing, Calibration of Equipment, Capital Projects, Change Control Systems, Chemical Process Development, Cross-Cultural Awareness, Cross-Functional Teamwork, Equipment Qualification, General Safety, Global Manufacturing, GMP Compliance, Maintenance Management, Maintenance Processes, Manufacturing Process Validation, People Leadership, Plant Maintenance, Preventive Maintenance, Process Optimization, Regulatory Compliance, Regulatory Inspections, Regulatory Requirements, Results-Oriented, Strategic Thinking, Technical Guidance {+ 1 more}
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.
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:
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.
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
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
07/10/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
Animal FeedVeterinaryHealth CareData ManagementBiopharmaClinical TrialsBiotechnologyMedicalPharmaceuticalData Center Automation
How much do Manufacturing jobs in North Carolina pay?
Based on 1506 listings with disclosed salaries, most manufacturing jobs in North Carolina pay between $69k–$165k per year. Individual offers vary with seniority, company size, and specialization.
How many Manufacturing jobs are open in North Carolina right now?
There are currently 8,785 open manufacturing positions in North Carolina listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in North Carolina?
Companies currently hiring include Corning Incorporated, Eaton, ABB, Butterball, RTX, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in North Carolina?
Yes — 733 of the 8785 open manufacturing positions offer remote or hybrid work (191 remote, 542 hybrid).
How do I apply for Manufacturing jobs in North Carolina?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.