Engineering, Specialist, Technical Operations Deviation Management

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you

Engineering, Specialist, Technical Operations – P2 (West Point Site Deviation Management support)

West Point Technical Operations is seeking highly motivated individuals to provide on-site engineering technical support within manufacturing facilities at the West Point location. The focus of the role includes Deviation Management, including Process and Environmental Monitoring Deviation investigations, with additional areas of responsibility/development depending on the area supported. The deviation management role includes investigation of process deviations (i.e. identifying root cause, recommending corrective/preventative actions, assessing product impact, and summarizing investigations in writing). The other areas of responsibility offer opportunity for further development and rotation to gain experience in different potential functional roles within Technical Operations. Limited additional shift or weekend coverage may be required based on specific assignments.

Individuals selected for this role will spend at initial period of time training and/or gaining deviation management and process support experience within the B29 Liquids Deviation Management team prior to movement to an area on the West Point site requiring Deviation Management support.

Position Responsibilities:

• Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
• As required, manage the IPT deviation management daily huddle to evaluate potential deviations, facilitate the discussions to align with technology and quality approvers / representatives on deviation classification and impact assessment.
• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
• Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.
• Supporting team and IPT safety, environmental, and compliance objectives.
• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
• Actively using and championing the use of our Company Production System tools, both in problem solving and day-to-day operational activities.
• Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation
• Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.
• Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
• Provides technical support to manufacturing for complex problems and issues including process/equipment.
• Collaborates effectively with the area Biotechnicians/Operators/Mechanics, support groups, Quality, and Planning.

Education:

• Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, or related discipline.

Required Experience and Skills:

• Minimum 1-year experience in direct experience or support to vaccine/pharmaceutical manufacturing (Technical Operations, Quality, Operations)
• Technical writing (e.g. investigations, technical protocols/reports)
• Investigative tools (e.g. 5-whys, fishbone).

Strongly Preferred Experience

• Two or more years of vaccine/pharmaceutical manufacturing experience (Operations, Technology, or Quality)
• Minimum 1-year experience in Deviation management and/or Complaints.
• Experience in Trackwise, MEDS, SAP, GLIMS, DeltaV use
• Experience in applying our Company Production System tools and mindset, both in problem solving and day-to-day operational activities

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

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If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/13/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R305454