Manufacturing Technology Manager

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Kindeva Drug Delivery is on a mission to solve drug delivery challenges and change patients' lives worldwide, and we are able to achieve this due to our innovative, collaborative team. If you want to grow your CDMO career and be a force for good, you will have everything you need to excel at Kindeva.

With over a century of experience in combination product development and manufacturing, Kindeva is truly a global force in drug delivery. We have state of the art facilities across the US and UK and our capabilities span delivery formats, from ideation through commercialisation.

At Kindeva, we manufacture more tomorrows. Our products change and save lives across the world, and we are committed to developing meaningful and powerful solutions for our partners and the patients we serve. Every member of our team contributes to this mission, making a real difference, every day.

Ready to take on a career that matters? Look no further, we are hiring for a talented Manufacturing Technology Manager to join our Clitheroe team.

OVERVIEW

An active member of the site management team, collaborating cross-functionally and across the Kindeva management network providing leadership and supervision to engineering professionals in a manufacturing operation to ensure EHS, quality, compliance, productivity, efficiency opportunities and improvements are implemented using latest problem solving and effective project management techniques.

Manager Manufacturing Technology Engineers to execute a diverse range of projects to resolve product and process performance roadblocks and improvements across the full production lifecycle of MDI valves and cans; from raw material production through to finished product release. Apply a combination of technical expertise, people leadership, project management skills and strategic thinking to ensure projects are aligned to business goals. Self-lead projects where required as described in the Manufacturing Technology Engineer job description to support the Clitheroe site.

ROLE RESPONSIBILITIES

1. Manage Manufacturing Technology Engineers to deliver a diverse range of projects across the full production lifecycle of MDI valves and cans, from raw material production through to finished product covering the following areas:

• Understands the impact of key events and decisions on safety, quality, service and cost across the manufacturing and supply chain operation.
• Design, develop, configure, optimize and qualify / validate / scale up / commercialise new and changed products, production / chemical processes, metrology systems (including automation, operational technology and mechatronic systems); from concept to implementation on time and to budget.
• Monitor product quality, identify technical issues and improvement potential, determine root cause and implement corrective and preventative actions (including annual product review APR/PQR).
• Maintain and sustain operational efficiency (cost and productivity) of products and processes including equipment design, performance (OEE) and modification.
• Supplier selection for raw materials, processes, equipment, components and services.
• Lean flow for factory design / operational layouts of manufacturing equipment

1. Assign, track and prioritise the project portfolio of projects and maintain a pipeline of future projects. Progress multiple changing priorities daily, balancing production support with project work.
2. Recruit, guide, motivate, coach, develop, set goals, monitor performance for the group, as individuals and as a team to maintain knowledge of all site products, processes, metrology and raw materials and in-depth specialty for specific processes, products and materials. Support engineers to self-learn through observation, research and seeking appropriate relevant training courses and/or expert internal guidance. Ensure team expertise is used to share knowledge and train junior members of the team, as well as cross functional employees outside of the team where needed.

1. Maintain consistent and aligned project discipline and record keeping across the team and projects.

1. Ensure the team are appropriately skilled to implement continuous improvement, lean six sigma, data analysis and problem solving know how and tools to improve processes and solve problems at Kindeva and suppliers. E.g. Minitab, Kepner Tregoe (KT), process mapping, cause and effect (C&E), failure mode and effects analysis (FMEA), fishbone, kaizen etc.

1. Manage key site forums such as the project and OEE reviews to facilitate cross functional stakeholder communication and identify new projects. Ensure the team presents updates within site (Tier process and project review) and up to/including CEO level as required by the business.
2. Approve and author new and changed technical and quality documentation within the quality management system, and project documentation within the project records including:
   • Technical/validation protocols and reports
   • Manufacturing records (MIS)
   • User requirement specifications (URS)
   • Engineering work requests (EWR)
   • Risk assessments (RA)
   • Management of change (MOC)
   • Standard operating procedures (SOP)
   • Work instructions (WI)
   • Finished product and raw material specifications
   • Quality agreements (QA)
   • Design manufacturing records (DMR)
   • Product performance assessment reports (PPAR)
   • Audit sheets
   • Quality test records (QTR)
   • Deviation reports (Dev)
   • Out of specification/trend reports (OOS-OOT)
   • Corrective and preventative action forms (CAPA)
   • Action items (AI)
   • Stock destruction notes (SDN)
   • Calibration assessment forms (CAF)
   • Product inspection forms (PI)
   • Drawing amendment requests
   • Material requisitions
   • Master data change forms
   • New item request forms
   • Project plans / timelines / decisions / minutes / slide decks etc.

1. Make provision for the team to support the other Kindeva sites and suppliers (MDI and Transdermal) with investigations and understanding related to MDI components and imaging of products, e.g. CT scanning, 3D printing and metrology systems.
2. Provide input and ideas into the strategic direction of the business.
3. Ensure the team work in compliance with company procedures to maintain quality and safety. Complete observation and feedback (O&F) reports and participate in site audits.

Desirable experience and qualifications:

• Bachelor's degree in a relevant field such as related to engineering, chemistry, pharmaceuticals.
• CI / Lean Six Sigma / Green Belt certification
• Line management in a technical arena
• Significant experience in related field
• Project management
• MDI / MDI component knowledge
• Pharmaceutical manufacturing / GMP
• Data analysis / Minitab
• Technical and quality document writing
• MS office (word, excel powerpoint etc)

Personal Skills:

• Acumen for technical complexity
• An engineering / problem solving mindset
• Works with autonomy
• Ability to self learn and research
• Personable
• Excellent communication skills
• Team player
• Agility for frequent change

What we will give to you:

Attractive compensation package

Company pension scheme (up to 10% employer contribution)
25 days holiday per year (plus bank holidays) plus service days after 5 years

Company sick pay

Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
Life assurance of four times life cover salary

Flexible working hours

Wellness programmes

Employee recognition program

Employee development

Free on-site parking

Discount and cashback at many retailers

Cycle to work scheme

Flu vaccinations

Employee referral scheme

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Other details

• Job Family Management II
• Job Function Management
• Pay Type Salary

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