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1+ months

Manufacturing Process Specialist

Kelly Services
Malvern, PA 19355
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a **Manufacturing Process Specialist** for a project engagement at one of our Global clients in Malvern, PA.


This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation, and sick/personal time. All KellyOCG employees receive annual performance reviews.


**Principal Responsibilities:**

As the Manufacturing Process Specialist, you are a technical expert supporting the manufacture of biological products, both on the site and across the network.

You will provide technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations.

You will monitor and trend key process parameters.

You will troubleshoot manufacturing problems as required and provide primary technical support.

You will identify and implement process improvements both locally and across the network.

You will support capital projects, site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert.

You will conduct technical and validation studies.


**Key Responsibilities:**

Provide primary (on floor) production support and technical support for the investigation and resolution of deviations and atypical events.

Partner with primary investigator to ensure consistent quality standards are maintained.

Help identify true root cause of investigations, assess product quality impact, and approve investigations as management technical representative of Cell or COE, as needed.

Recommend, own, and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences, following up to determine if corrective actions adequately addressed root cause of NC event.

Track deviations, events and key process parameters and provide reports to management on trending, and status as requested, recommending corrective actions for any trends identified, and collaborate with management to review and approve events and deviations.

Act as a SME to customers, providing guidance on deviations, investigations, and issues pertaining to quality of product.

Identify and implement process improvements within the change control system and related to safety, environmental, quality, compliance, productivity, yield, and cost, partnering as applicable.

Develop business cases for projects and present to site leadership for approval.

Initiate and execute change controls for projects and work with management to allocate group resources to assist with change control, equipment startup, and technical training, assuring regulatory compliance and technical feasibility of proposed changes.

Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.

Provide technical support concerning the change control system and for process and cleaning validation maintenance and verification and assist with cleaning cycle optimization and revalidation efforts.

Extract process data from SCADA and Delta-V servers for use in databases maintained by technical operations and utilize database to monitor process performance and proactively troubleshoot operations.

Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.

Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).

Demonstrate expertise in a number of the following areas: cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, defiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities.

Provide documentation support for SOP/ Batch Record revisions, identify, and communicate necessary document changes to document management group to ensure timely revision to all SOP and batch records and review and approve SOP and Batch record revisions.


**Qualifications**

Minimum Bachelors degree required; focused degree in Technical area preferred

Requires 3 plus years of experience in a manufacturing environment, biopharmaceutical, or pharmaceutical industry

Ability to interpret and carry out a variety of technical or other instructions furnished in written, oral, mathematical, diagram or schedule form or other nonverbal symbolism (formulas, scientific equations, graphs, etc.)

Ability to apply principles of logic or scientific thinking to define and deal with intellectual and practical problems, involving abstract and concrete variables in standardized situations, and collect data, establish facts, and draw valid conclusions

Ability to make innovation part of the site agenda and be an active driver of innovation, thinking outside of the box and challenging others to do the same


**Preferred:**

Compliance experience preferred, including adherence to local, state, and federal regulations and guidelines (EPA, OSHA, etc.); cGMP or FDA is helpful

Familiarity with SAP, TrackWise, LIMS is helpful


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-10 Expires: 2021-06-24

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Manufacturing Process Specialist

Kelly Services
Malvern, PA 19355

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