As Senior Manufacturing Engineer you will sit within the Manufacturing Technology Group supporting our manufacturing, filling and packaging operations at our Loughborough site.
This is an exciting role to support an expanding team, where you will use your technical expertise and product/process understanding to maintain and improve existing, with the introduction of new, manufacturing and packaging processes.
You will adhere to, demonstrate and coach the team holding a good understanding of Safety, Quality and HR polices e.g. GMP, EHS, Specifications, Methods and Manufacturing/Packaging documentation.
Key Responsibilities
- Identify and manage improvements to process capability, capacity and reduction in unit cost for areas of ownership.
- Manage the introduction of new equipment and processes within operations, initiate, prepare, execute and report validation documentation for the qualification / validation of equipment / processes.
- Adhere to Good Manufacturing Practice (GMP) and carry out all tasks with an advanced understanding of regulatory guidelines as well as ISO standards.
- Demonstrate broad knowledge of information resources that can be used to assess problems and make decisions.
- Solve complex problems with the use of data to make decisions.
- Prepare detailed documentation to record deviations.
- Determine root cause analysis or provide technical guidance to manage corrective and preventative actions or facilitate change in a timely manner.
- Lead projects that expand upon business units.
- Demonstrate advanced understanding of function project framework, life cycle and project management.
- Allocate project resources and ensure relevant risk management/contingency is in place.
- Demonstrate a good working knowledge of manufacturing, filling and/or packaging processes to provide technical support and guidance to assist the mitigation of risk.
- Provide product understanding to support the generation of product quality reports.
Skills & Experience
- 5+ years’ previous experience in a similar regulated environment with expert knowledge in any of the following: Validation/New Product Introduction (NPI)/Technical Transfer or Market Product Support.
- Educated to degree level or equivalent in a relevant Engineering, Pharmaceutical or related field.
- Relevant work experience within the field of the medical device / drug product industry is an advantage.
- Good understanding of the pharmaceutical industry standards and regulatory requirements (cGMP, FDA, EMA) is preferable.
- Knowledge of lean manufacturing principles, Six Sigma, or other continuous improvement methodologies.
- Demonstrated experience in supervising, leading and coaching staff.
- Computer literate, familiar with Microsoft Word and Excel.
Key Capabilities
- Inspire and motivate the team to achieve excellence and accountability.
- Lead by example with integrity, professionalism, and accuracy.
- Excellent interpersonal skills, both written & oral.
- Strong verbal communication skills, especially in cross-functional/leadership meetings.
- Able to work both as part of a team but also act independently.
- Enthusiastic and determined to achieve set objectives.
- Possess strong computer skills and excellent organizational capabilities.
- Demonstrate flexibility, strategic thinking and drive to succeed.
- Demonstrate a firm understanding of the overall role within the wider business.
- Adapt to changing priorities, timelines, and expectations without compromising on quality.
- Maintain a high standard of accuracy, completeness, and documentation.
- Champion data integrity and a right first-time culture.
What we Offer
- 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.
- Private Medical Insurance.
- 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.
- Wellness programmes.
- Employee recognition program.
- Free on-site parking.
- Discount and cashback at many retailers.
- Cycle to work scheme.
Additional Information
Location: Derby Road, Loughborough
All applicants must be eligible to work in the UK.
We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.
Kindeva is an Equal Opportunity Employer
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