Lead Validation Engineer Job in Galway, Ireland

Lead Validation Engineer Job Description

Description

Bioniche Pharma (a Mylan Company) based in Kilroe, Inverin, Co. Galway (25Km west of Galway City) is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, with expertise in injectable hyaluronic acid products for use in orthopedics, rheumatology, urology and dermatology.

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company ranks among the top five generics companies in several markets around the world and is the largest U.S. based generics manufacturer in the world employing over 18,000 people worldwide.

A vacancy has arisen within the Validation Department of Bioniche Pharma based in Inverin, Co. Galway for the position of Lead Validation Engineer.

The successful candidate will lead and project manage validation/qualifications and co-ordinate all validation activities within Bioniche Pharma (Mylan Institutional) and will report directly to the Validation Manager.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Coordinate and supervise the preparation, review and issuing of validation protocols and reports (this to include equipment, cleaning, process, sterilisation and computer system validation).
2. Execute validation/qualification studies when required.
3. Lead validation efforts with cross functional teams to deliver validation projects to schedule.
4. Liaise with Manufacturing, Engineering on the completion of risk assessment for process improvements.
5. Determine levels of importance or risk to be assigned to elements under review – using scientific rationale to justify scale of effort.
6. Ensure that all validation activities are adhered to and closed as per the stage and gate process for site projects.
7. Contribution in areas such as change control, IRF, CAPA’s, Policy writing and VMP’s.
8. Lead re-validation activities and generate SOP’s / other documentation as applicable.
9. Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
10. Present validation systems at internal and external audits and support quality assurance programmes in conjunction with the Validation Manager.
11. Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.
12. Perform other duties as required.  

Lead Validation Engineer Job Requirements

QUALIFICATIONS 
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required. 

KNOWLEDGE  
Must possess knowledge of pharmaceutical and medical device regulatory requirement for FDA and IMB regulated environments.

SKILLS AND ABILITIES
Must possess strong project management and organizational skills. Self-motivation and drive. Communication-strong written oral and presentation skills. Excellent leaderships skills.
     
SUPERVISION
Position directly supervises  three employees.  Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) in Chemistry, Microbiology or Engineering and 5 years of experience in a validation role in either the medical device or pharmaceutical industry.  However, a combination of experience and/or education will be taken into consideration. 

LICENSES/CERTIFICATIONS
None.

LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.  Ability to work with managers or directors and communicate ambiguous concepts.  Ability to present to groups across the organization.

MATHEMATICAL SKILLS
Ability to add, subtract, multiply and divide.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table.  Intermittently sitting, standing, walking or stooping.  Light/Medium Lifting may be required when executing validation projects. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.  May be required to lift or maneuver boxes or containers using lifting equipment, as well as physically pushing, rolling or lifting if performing Qualification /Validation execution.  May be required to wear personal protective equipment including but not limited to: respiratory protection, safety glasses, hearing protection, safety shoes and protective clothing.  

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Normal Office Situation with requirements to work in the production environment when Validation/Qualifications are being performed.

Bioniche Pharma can offer the successful candidate challenging experiences and unlimited opportunities for personal growth and professional advancement.

Bioniche Pharma is an equal opportunities employer

Bioniche Pharma does not require Agency Assistance with this role - thank you.    

The recruiter is interested in your answers to the following question(s). Please place your answers in the email you send when applying for the job. 

Question 1:
Do you have a minimum of a Bachelor's degree (or equivalent) in Chemistry, Microbiology or Engineering?

Question 2:
Do you have 5 years experience in a validation role in either the medical device or pharmaceutical industry?

Question 3:
What are your salary expectations & availability?

Lead Validation Engineer Application Information

Please apply with your CV and cover letter by the 'apply' button below.

Lead Validation Engineer Summary

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