Validation Engineer in London, London, United Kingdom

Reporting in to: Production Manager

Location: London, United Kingdom

Job Duration: 10 months (possibility of permanent position after initial 10 months)

Profile:

The Validation Engineer is responsible for carrying out validation activities as they

relate to facility, utilities equipment qualification/ IQ/OQ/PQ, process validation,

manufacturing and packaging processes, cleaning validation processes, site validation

plan planning, risk assessment, change control, CAPA, deviations, investigation,

development of validation strategies. This position assures that all validation activities are executed with the highest quality and meet all applicable SOP’s and regulatory standards.

Main Duties:

1. Assist with Validation projects independently and including the oversight of third

party contract assignments

2. Demonstrate expertise in Equipment Qualification, Facility commissioning and

warehouse temperature

3. Write or review validation/qualification protocols and respective reports

4. Review, maintain and develop validation packages in support of commercial

product in compliance with current regulations/standards

5. Execute Validation/Qualification plans to support product launches, process

improvements, and continued commercial production

6. Initiate any applicable change controls with respect to validation activities, track

and follow-up with the required departments to close the change controls

7. Execute or review IQ/OQ/PQ protocols of process equipment and facility

modifications and suggest any required changes.

8. Execute or review the protocol reports and ensure that qualifications are

performed properly

9. Create any new SOP’s and revise the existing SOP’s applicable to validation;

train and mentor department personnel

10. Demonstrate ability to work independently with multi-disciplinary trades,

equipment/facility/utility vendors to complete qualification projects in stringent

deadlines.

11. All other validation related duties as assigned

Qualifications and person specification:

1. BS/MS in Engineering or equivalent

2. 4+ years’ experience in facility/utility and equipment qualification in the

pharmaceutical industry

3. Excellent knowledge of cGMP in the pharmaceutical industry

4. Working knowledge 21CFR part 11

5. Excellent computer skills; Microsoft Excel, Word, and PowerPoint

6. Strong problem-solving skills, strong verbal and written communication skills,

and the ability to work independently.

7. Must have strong interpersonal and communication skills, be a team player and

be willing to work in an environment where individual initiative, accountability to

the team, and professional maturity are required

8. Ability to establish and maintain working relationships with co-workers

9. Superior organizational, problem-solving and multitasking skills, with the ability

to pick-up and learn new tasks quickly

For more information about this role please contact our London office

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