Job Description
An amazing opportunity has arisen for a Shift Engineer. This role will be part of our Process Engineering and Automation Hub, with day-to-day responsibilities in the Manufacturing Self Directed work team in our new state of the art single use multi-product biotech facility. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists. The Shift Engineer will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. The Shift Engineer will be responsible for the use of process engineering systems and approaches during processing shifts for monitoring equipment and process performance, being the main point of contact for real time process monitoring and troubleshooting, ensuring equipment is performing optimally and safely to support production activities, acting as subject matter expert (SME) support to deviation investigations, and using risk management techniques to prioritize activities and initiatives. Ongoing optimization of process equipment and development of future breakthrough business solutions will be key focus areas. The role will involve being a key point of contact and liaison between Manufacturing Operations and Manufacturing Technical Support, working as part of a team of engineers who will be responsible for ownership and management of change of the electronic batch records, identifying equipment, recipe and process improvements and managing and controlling changes in these areas. The shift engineer will be imbedded on the manufacturing floor with production personnel during shift operations in order to provide real time response to issues and play a key role in the coaching and development of the Manufacturing team.
This role is a site based role.
This is a shift based role
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Get actively involved by participating in inspections, GEMBA’s and Go-See’s.
- Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
- Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
- Routinely talk about any safety issues you are concerned about.
- Know the hazards of the tasks you are performing, actively conduct risk assessments for inclusion into operational SOPs.
- Challenge yourself before starting any task and identify safety improvements and be an active participant of our site safety standards challenging the status quo. If something is out of the ordinary, or something changes, step back and reassess, if in doubt do not do it.
- Ensure you are effectively trained for the work you need to do, challenge the safety training if it is not effective.
- Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
- Be a visible leader of safety initiatives and stay actively involved in safety forums.
- Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
- Provide coaching for your team members as part of the continuous improvement mindset.
- Role model the behaviours that creates a culture of dignity and respect.
- Act as technical coach and leader for the self-directed work team in areas relating to process, equipment, and automation knowledge.
- Identify improvement opportunities, perform technical troubleshooting and successfully implement solutions.
- Support the implementation of site strategy and business unit strategy by identifying appropriate initiatives for applicable improvements to the value stream. In some instances support corporate initiatives and projects as required.
- Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
- Get actively involved in supporting the implementation of the lean management system.
- Act as an SME on activities involving the design, specification, selection, equipment performance, engineering CQV, technical drawings, vendor management, engineering assessment of changes, conducting and leading investigations.
- Play a key role in the commissioning and qualification activities on site, acting as a lead end user for systems as they transition across to the operations teams. Ensure consistency between recipe design and technical SOPs.
- Responsible for timely updates of site achievements and challenges.
- Engage in implementing innovative solutions that drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
- Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
- Be an SME on specific EBRs in the facility, providing technical input on changes required to meet the demands of the business or in response to any requirements for process changes that may occur. Pull together cross functional teams to troubleshoot issues, inform / consult stakeholders to reach consensus, and implement corrective actions that will move the production processes forward in the facility.
- Own the batch recipe on the PAS (process automation system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.
- Act as a key SME for the introduction of new process equipment into the facility, and provide technical training or support for the operations based manufacturing personnel as equipment is brought on line
- Play a key role in developing process engineering related documents, technical SOPs, reviewing automation related functional design specifications and generating technical reports
What skills you will need:
In order to excel in this role, you will more than likely have:
- Minimum of a Bachelors Level 8 degree in technical field (Science or Engineering) or equivalent
- At least 3-5 years’ experience in the biotechnology and/or pharmaceutical industry desirable, (preferably both) or equivalent.
- Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
- Proven record of accomplishments in a regulated industry.
- Experience with automated systems (PAS systems, MES systems) is desired
- Experience leading significant process or plant improvement projects
- Strong operations support background ensuring value added contribution and oversight.
- Experience working in a GMP manufacturing environment.
- Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
- Establishes stretch goals for self to allow the SDWT or Hub Team deliver on their priorities.
- Identifying and communicating risks in area of responsibility and across the site.
- Creating strategies and plans to manage risk within the value stream and SDWT and Hub teams. Internal and External Contacts
- List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples.
- Collaborates across the Network and continuous improvement teams across the Organisation.
- Key collaboration with the Self-Directed Work Teams and Hubs across the enterprise. Collaborates with cross-functional teams to deliver the site objectives.
- For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in our company and through external forums to drive business excellence.
- Collaborates with Plant and Project Engineering groups on equipment issues and plant modifications
- Works closely with the Automation team on site to ensure that process recipes are fit for purpose and aligned with the technical procedures operating within manufacturing.
- Collaborates with MS&T on new product introductions to ensure that the plant is set up to deliver on new process introductions or process changes
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/25/2024
*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.
Job Posting End Date:09/25/2024
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:R301966