Lead Tech, Maintenance
HireLifeScience
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Benefits offered by this job
Job summary
HireLifeScience in Durham, NC seeks a Lead Tech, Engineering to support a capital project start-up. You will help install, operate, maintain and troubleshoot biopharmaceutical manufacturing equipment, develop SOPs, and support validation activities while collaborating with operations, QA, and automation teams.
The role emphasizes GMP compliance, safety, and cross-functional teamwork to ensure equipment reliability and process efficiency in a growing pharmaceutical facility.
Qualifications
- Must have GMP regulatory familiarity.
- Proficient in PLCs, CMMS, and MS Office.
- Excellent written and oral communication skills.
Responsibilities
- Perform routine maintenance on process equipment and utilities.
- Support calibration, validation testing and root cause investigations.
- Develop SOPs and preventive maintenance plans.
- Interface with operations, QA, automation and other groups.
Skills
Education
Tools
Job description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
The Lead Tech, Engineering is a member of the Engineering team providing technical support within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.
The candidate will support the installation, operation, maintenance and/or troubleshooting of biopharmaceutical manufacturing equipment such as washers, autoclaves, tanks, bioreactors, filtration skids, filling lines, lyophilizers and isolators. - Develops Standard Operating Procedures (SOPs) and Preventative Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups as required.
- Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to:
- Process Equipment (e.g. Filling Machine, Lophilizer)-
- Support Equipment (e.g. washers, autoclaves, incubators)
- Utility Equipment (e.g. Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems)
- Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC))-
- Clean-In-Place (CIP) Systems-
- Maintenance Equipment (e.g. tools and calibration equipment)-
- Assist with execution of calibration, automation, validation and additional testing, as required
- Decisions are guided by policies, procedures and business plan; receives guidance from manager.
- Contributes to the performance and results of the department.
- Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
- Responsible for assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes.
- Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges
- Develop and execute engineering change request (ECRs), as necessary.
- The successful candidate should be able to examine an issue from perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause.
- Provide input to investigate deviations, with responsibility to interface with approvers.-
- Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures
- Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses, etc.-
- Position requires clean room gowning during performance of job duties
- Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates
- Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems
- Support daily meetings to facilitate flow of information up/down through the organization
- Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
- Serve as a Subject Matter Expert (SME) during tours to provide area/process overview information to visitors/auditors upon request.
- Working as a SME, provide necessary training for system maintenance as needed.
- Order and maintain spare parts for assigned process equipment
- Ensure inventory transactions are complete, timely,-and accurate
- Recognize and communicate opportunities for cost savings
- Bachelor Degree in Engineering, Science or an associate degree and 2 years experience in a production and/or calibration and/or maintenance background
- 6 years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems).
- Familiarity of regulatory requirements in accordance with GMP manufacturing operations
- Good oral and written communication skills
- Physical requirements - Must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking, bending, crawling, and stooping is required.-
- Proficiency in computer systems and applications including but not limited to:- Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems
- Effective maintenance, troubleshooting, and problem-solving skills required
- Routine shift will 3/2/2 12 hour day Available for "On-Call" work rotation (during off-hours) and weekend overtime, as needed.
- SAP experience related to plant maintenance and spare parts procurement systems
- cGMP experience in a sterile, bulk or finished pharmaceutical environment
- Experience authoring PM/calibration job plans and management of spare parts
- Installation, operation, maintenance and/or troubleshooting experience with biopharmaceutical manufacturing equipment such as washers, autoclaves, skids, tanks, bioreactors, and filtration skids
- Ability to read P&ID's, electrical drawings, blueprints, etc.
- Ability to manage multiple priorities and advance several tasks in parallel
- Knowledge of Allen Bradley PLC's, Siemens Apogee BAS.
The salary range for this role is: $85,500-$134,700
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.
Building Automation Systems, Building Automation Systems, Competency Management, Computerized Maintenance Management Systems (CMMS), Corrective Maintenance, Electrical System Troubleshooting, Equipment Maintenance, HVAC Engineering, HVAC Maintenance, HVAC Systems, Hydraulic Systems, Instrumentation Systems, Instrument Calibrations, Inventory Management System, Lockout Tagout, Maintenance Scheduling, Maintenance Services, Manufacturing Equipment, Manufacturing Maintenance, Material Handling Equipment, Mechanical Troubleshooting, Parts Inventory, Parts Sourcing, People Management, Plant Maintenance {+ 10 more}
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:
EEOC Know Your Rights
EEOC GINA Supplement
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.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
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
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.
Regular
No relocation
No
No Travel Required
Not Applicable
1st - Day
No
n/a
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