Senior Manager Process Engineering Holly Springs, NC

Msccn

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.

What you will do

Lets do this! Lets change the world! In this vital role you will oversee the engineering team lead technical projects and drive innovation in product design and manufacturing processes. You will solve complex engineering problems optimize processes and ensure the companys engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

The Senior Manager Process Engineering will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director partnering closely with the corporate engineering team to design build commission and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start-up focusing on Process engineering and plant equipment as well as hiring and training the staff required to support startup and operations.

Key responsibilities include:

Site design construction start-up and operational readiness:

Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.

Ensure systems are installed operating safely and comply with pertinent environmental health/safety practice rules and regulations.

Perform engineering assessments for plant equipment operations implementing equipment modifications and supporting engineering runs in support of new product/technology introductions as required.

Site Operations:

Provide system ownership for process equipment typically used in biologics manufacturing including Upstream (Seed train production Bioreactors Harvest) and Downstream Purification (e.g. Chromatography and viral Filtration skids UFDF) and CIP/SIP Skids.

Lead a team of Process Engineering professionals and serve as the main point of contact for Process and equipment engineering function.

Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement partnership and knowledge sharing. Provide development opportunities feedback and actively listen to staff.

Effectively collaborate with key customers and support groups (e.g. Manufacturing Quality Process Development Maintenance network partners).

Work with original equipment manufacturers for breakdown and planned maintenance of process equipment.

Work with integrated service providers for day-to-day operational activities breakdown and planned maintenance.

Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements identifying design requirements and translating these requirements into process equipment/system design specifications and supporting the construction startup and validation of equipment.

Develop equipment maintenance programs ensure the availability of spare parts and coordinate maintenance activities to ensure systems are in proper working order.

Ensure plant readiness and quality and regulatory compliance for internal audits external agency audits and partner audits for the process equipment.

Provide system guidance to identify performance risks and implement risk reduction strategies.

Provide technical support to troubleshoot identify and resolve process and system issues as needed.

Provide strategic tactical management and leadership to ensure 24x7 day-to-day reliability of plant operations.

Participate in the budgeting process for process engineering including forecasting costs managing expenditures and ensuring efficient allocation of resources.

10% domestic/international travel

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The collaborative individual we seek is a leader with these qualifications:

Basic Qualifications

Doctorate degree and 2 years of engineering experience

Masters degree and 6 years of engineering experience

Bachelors degree and 8 years of engineering experience

Associates degree and 10 years of engineering experience

High school diploma / GED and 12 years of engineering experience

And

2 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources

Preferred Qualifications

Bachelor s degree in Chemical or Mechanical Engineering or related technical field.

8 years of relevant work experience with 5 years experience in Biopharmaceutical operations/manufacturing environment focused on process and plant engineering function.

Demonstrated people management/leadership experience.

Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train production Bioreactors Harvest) and Downstream Purification (e.g. Chromatography and viral Filtration skids UFDF) and CIP/SIP Skids.

Experience with Tech Transfer Process Design and Commissioning & Qualification.

Experience working in a regulated environment (e.g. cGMP OSHA EPA etc.) experience interacting with regulatory agencies and inspectors and familiarity with GMP quality systems/processes such as change control non-conformances corrective and preventative actions and qualifications/validation

Familiarity with designing and operating equipment used in biopharmaceutical manufacturing

Independent ambitious organized able to multi-task in project environments and skilled in communication facilitation and teamwork

Strong leadership technical writing and communication/presentation skills

Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information

Work schedule flexibility as required to support 24/7 operations requiring occasional after-hours engineering coverage

Required Experience:

Senior Manager

ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. I...