Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
R&D Engineer
W. R. Grace & Co.-Conn.
Columbia, MD
Apply Now >
Systems Engineer \/ Analyst
Chantilly, VA
Apply Now >
Sr Process Engineer
W. R. Grace & Co.-Conn.
Columbia, MD
Apply Now >
Downstream Manufacturing Associate
Columbia, MD
Apply Now >
ETS Engineer
Gaithersburg, MD
Apply Now >
View more jobs in Gaithersburg, MD
View more jobs in Maryland
View Similar Jobs

Job Details

Production Engineer

Gaithersburg, MD

Apply for this job


Production Engineer - GMP MFG Equipment
Major pharmaceutical R&D and manufacturing organization seeks Engineer to support GMP manufacturing operation. This position reports to the Associate Director of Engineering Technical Services supporting GMP clinical manufacturing. Responsible for maintaining reliable equipment performance in one manufacturing area at Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.
-Subject Matter Expert (SME) manufacturing equipment in assigned area
-Resolves daily operational issues in assigned area
-Performs troubleshooting, maintenance, and process performance optimization
-Installs or replaces components and equipment.
-Supports shutdown and return to service activities
-Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans
-Coordinates maintenance activities with Facilities / Coordinates service contracts and work of outside vendors.
-Obtains quotes and purchases spare parts and equipment, and adds parts to the SAP inventory system
-Monitors equipment performance. Identifies equipment issues and helps develop technical solutions
-Determines process requirements. Helps design, install, and commission new processes and equipment
-Writes cGMP documentation (SOPs, MPRs, protocols, etc.)
-Writes other documentation including: user requirements, specifications, protocols, HECPs, drawings, and reports
-Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs.
-Performs GMP change control activities.
-Instructs staff on process/system integration and operation. Develops training plans.
-Supports new engineering projects. Creates project scopes, URS, and timelines
-Represents Manufacturing and Engineering Services on equipment projects managed by other engineering groups
-Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy
-Evaluates new equipment technologies. Participates in tech transfers
-Provides on
-call support and works overtime as needed.
-Often troubleshoots equipment problems and may perform corrections outside of established procedures. EDUCATION:
-Bachelor’s degree in Engineering (Chemical Engineering preferred) or Life Sciences. (Other candidates with extra experience may be considered) EXPERIENCE:
-Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus.
-Prior experience with production scale biotech equipment a plus.
-Candidates without a BS in engineering require a minimum of 2
-years of experience in GMP biotech manufacturing REQUIRED SKILLS:
-Good at trouble shooting and problem solving.
-Good oral and written communication skill, and good interpersonal skills
-Good interpersonal skills

Company info

Sign Up Now -

Similar Jobs:
Manufacturing Engineer - Fabrication
Location : Washington Navy Yard, DC
Location: Washington Job type: Permanent Sector: Manufacturing Category: Engineers Jobs Boeing Commercial Airplanes Fabrication Organization is seeking a Mid-Level Manufacturing Engineer to support developmental, test and emerge...
Manufacturing Engineer - Equipment
Location : Gaithersburg, MD
**Job Details:** **Industry:** Biopharmaceutical **Work Location:** Gaithersburg, MD **Job Title:** Manufacturing Engineer - Equipment **Duration:** 6 Months (Temporary/Contract) Possible extensio...
Area Sales Manager, U.S. West
Location : Columbia, MD
Requisition ID: 2329 Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The company's two industry-leading business segments-Catalysts Technologies and Materials Techn...
I like the volume of jobs on EmploymentCrossing. The quality of jobs is also good. Plus, they get refreshed very often. Great work!
Roberto D - Seattle, WA
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ChemistryCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ChemistryCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ChemistryCrossing - All rights reserved. 21