Oferta de trabajo: Deviation Management Specialist - I (Assistant)

Our client, one of the largest Pharmaceutical companies in USA is looking for a Deviation Management specialist at West Point, PA. Client is looking for someone who has expertise in writing Technical Documents, Deviation management and investigation skills.

Job Title: Deviation Management Specialist - I

Duration: 12 Month Contract

Location: Onsite - 770 Sumneytown Pike, West Point, PA 19486

• This is position is a site-based assignment and requires the employee to work at the site M-F.

• Two days of remote work per week may be available, work permitting, but is not guaranteed.

• Off-shift or weekend coverage may be required based on business unit needs and specific assignments.

Hours: M-F 8:00am - 5:00pm

Must have deviation investigation experience and technical writing experience.

Qualifications:

• Education Minimum Requirements: B.S. degree in Engineering or Sciences.

Required Experience and Skills:

• Minimum one (1) year post-bachelor’s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with <1 year experience).

• Demonstrated ability to drive results to hit assigned due dates.

• Strong communication, collaboration skills and ability to drive accountability.

• Strong problem-solving skillset

Preferred Experience and Skills:

• Vaccine manufacturing

• Sterile processing

• Experience authoring

• Technical writing (e.g. investigations, technical protocols/reports)

• Investigative tools (e.g. 5-whys, fishbone)

• Experience authoring investigations for atypical events in a manufacturing environment

Responsibilities:

• The Deviation Management Contractor will be responsible for technical support to vaccine manufacturing.

• This engineer will be a member of the Technical Operations Deviation Management team within the manufacturing division at the West Point site.

• The primary responsibility of the individual will be investigation initiation and closure associated with manufacturing deviations and development of actions in response to these deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing).

• Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/equipment actions, and other related duties.

• This position will require development of technical expertise of process and product knowledge.

Responsibilities include:

• Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.

• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.

• Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.

• Assures consistent application of standardized work, engineering, and process tools.

• Provides technical support to manufacturing shop floor for problems and issues.

• Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – M anpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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