Job Details: Industry: Biopharmaceutical Work Location: Gaithersburg, MD Job Title: Manufacturing Engineer Duration: 6 Months (Temporary/Contract) - Possible extension Manufacturing Engineer - Gaithersburg, MD Kelly Services is currently seeking a Manufacturing Engineer for one of our top clients in Gaithersburg, MD . JOB DESCRIPTION: Job Title: Manufacturing Engineer Job Description: This position reports to the Associate Director of Engineering Technical Services supporting GMP clinical biomanufacturing. Responsible for maintaining reliable process equipment performance in one or more manufacturing areas at the Manufacturing facilities including cell culture, purification, and support systems. * Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment in assigned area(s) * Resolves daily operational issues in assigned area(s) * Manages projects and coordinates shutdowns. * Supports new engineering projects. Creates project scopes, URS, and timelines * Performs troubleshooting, corrections, and process performance optimization * Monitors bioprocess 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, change controls, validation protocols, etc.) * Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs. * Performs GMP change control activities. * Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans * Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy * Provides on-call support and works overtime as needed. EDUCATION: Bachelor's degree in Engineering is preferred. EXPERIENCE: Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus. Prior experience with production scale biotech process equipment a plus. Prior experience with Trackwise 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 admin skills * Good interpersonal skills PROBLEM SOLVING COMPLEXITY: Works on routine technical problems of limited scope and complexity. IMPACT: | Completes many routine tasks and helps contribute to the completion of some non-routine tasks | Contributes to completion of milestones for specific projects. * Failure to achieve results or erroneous decisions may cause delays or product loss. FREEDOM TO ACT: * Works with moderate supervision, and usually follows established procedures. * Receives training on routine work and detailed instruction on new assignments * Often troubleshoots equipment problems and may perform corrections outside of established procedures. Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including: Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group-rate insurance options available immediately upon hire* Apply Today! Why Kelly (R) ? Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests. About Kelly Services (R) As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.