Validation Engineer ( m/f/d) at Gerresheimer

Skopje, Centar Municipality, North Macedonia -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Engineering, Industrial Engineering, Quality Assurance, Validation, Quality Management, Statistical QM Methods, Problem-Solving Methods, Technical Understanding, Project Management, Analytical Competence, Structured Working Method, English Proficiency

Industry

Machinery Manufacturing

Description

Company Description Gerresheimer is a leading global partner to the pharma and healthcare industry. Since its foundation in Germany in 1864, the publicly traded company now operates worldwide with 10,000 employees and generates revenue of €1,4 billion. Gerresheimer’s product portfolio includes pharmaceutical packaging and products for the safe and simple administration of medicines, i.e. insulin pens, inhalers, pre-fillable syringes, injection vials, with manufacturing facilities in Asia, Europe and North-and South America. Gerresheimer Skopje as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. Please note that Gerresheimer Skopje is a smoke free plant. Job Description Coverage of all manual activities (safety / order / cleanliness) in the immediate vicinity of the machine, including the necessary packaging activities according to specifications and in compliance with internal requirements. Independent visual inspection (100%) of parts at the SGM Packaging of goods at the SGM according to specifications Equipping the SGM with inserts according to specifications Creation of the associated production documentation according to instructions Support of ongoing production according to specifications and instructions Qualifications Knowledge as typically acquired during at least 3 years of technical university studies (e.g. mechanical engineering, industrial engineering, or similar) and extended by at least 5 years of relevant professional experience in the areas of quality assurance, qualification and/or validation. This function requires special knowledge in the areas of verification and validation of processes & qualification of equipment. Knowledge of quality management, QM methods and QM guidelines Knowledge of IT applications (e.g. Office programs, MES, QM system) Very good knowledge of statistical QM methods Knowledge of problem-solving methods (e.g. KT) Good technical understanding in dealing with specifications User knowledge of project management methods Excellent analytical competence (especially in the field of interpretation of results and derivation of further measures) Structured working method Proficient user in English Language Willingness to international business travel within the first year of the employment as on boarding will be mainly in our facilities in Germany Employment will be with our company in the Republic of North Macedonia Additional Information All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.

Responsibilities

The Validation Engineer will cover all manual activities related to safety, order, and cleanliness in the vicinity of the machine, including packaging activities. They will also conduct independent visual inspections of parts and support ongoing production according to specifications and instructions.