Validation Engineering Manager

About the role:

The Validation Manager will be responsible, with a hands-on approach, for the maintenance, governance, execution, and approval of process validation documentation within the specific site. They will be the subject matter expert on process validation strategy, execution, and risk management activities, ensuring compliance is met and site is audit ready.

Your key duties and responsibilities:

• Lead a local team of Validation engineers at Osted IC unit.
• Review, plan, schedule and implement validation activities for manufacturing equipment and processes within agreed timescales.
• Maintain a Validation Plan, review and implement all necessary standard operating procedures for ConvaTec processes, manufacturing equipment installation, operational qualification, performance qualification (PQ), requalification and revalidation of critical systems in line with GMP requirements / company policies and procedures.
• Developing, maintenance and ownership of site validation procedures (auxiliary local SOPs/WIs) for Osted unit in a way they are aligned and compliant with corporate validation SOPs and IC QMS.
• Responsible for Site Validation Master Plan (SVMP) at OSTED.
• Developing, maintenance and ownership of validation remediation activities in case any incompliance within validation area is observed or discovered. This is preferably related to Osted site with likely impact on entire IC business unit. Close cooperation with Reynosa site to make sure new/ changed procedures in IC are communicated and aligned.  
• Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
• Revalidation assessments – oversee compliance with the site revalidation schedule and SMVP, ensuring the plant is audit ready.
• Guidance and support for maintaining current state of site-specific validation through continuous process verification.
• Ownership of the local validation state overview (local validation database) ensuring all records are up to date and relevant validation documentation reference is traceable for all manufacturing equipment and processes on site.
• Provide validation expertise with regulatory compliance guidance and direction to meet with GMPs, FDA 21CFR820.75, ISO 13485.2016 7.5.6., GHTF/S63/N99-10:2004
• Provide a direction to local project team and engineers for execution of validation and writing project specific VP and protocols IQ/OQ/PQ validation documentation.
• Participate in Management Review Meetings and provide status and progress reports for validation/qualification activities or projects ensuring timely and effective communication and escalation where required.
• Support the early equipment management (URS, FAT, SAT) when procuring new equipment to ensure build is carried out according to URS and VP deliverables.
• Allocate and validation resource to support early equipment management phase and execute core validation activities for all planned projects utilizing global validation tool in appropriate advance. Validation engineer resource pool management.  
• Support inputs to PFMEAs and project plans within manufacturing process validation.
• Effectively work with cross functional site teams to ensure the validated state of the manufacturing processes are maintained.
• Provide technical support to Regulatory Affairs to assist with the update of the Essential Requirement Checklist and technical files for submissions to the Notified Body.
• Accountable for presenting site-specific validation to regulatory bodies (e.g., BSI, notified bodies). Assist with the enforcement of compliance of validation procedures through regular audit activities. 
• To ensure compliance with the legislative and internal requirements of the local EHS 
• To ensure CAPAs associated with validation area are handled in a way the milestones are delivered meeting the pre-defined target dates agreed with NC/CAPA team.
• To ensure periodic revalidations/PSEs are in place in a way to prevent any backorders.

Skills & Experience:

• This is considered an advanced role and requires thorough process knowledge and experience with process validation engineers and project planning.
• Act with integrity, make risk management decisions based upon fact, escalate the issues when company strategical interest or compliance are in a risk.
• Comprehension of the validation life cycle and how it can be applied efficiently and remain compliant on intercompany level / multiple BUs.
• Proven experience of equipment process validation.
• Excellent understanding of Good Manufacturing Practice (GMP) and Quality Systems in a regulated environment.
• Ability to communicate effectively with individuals at site levels and provide a proactive approach to solving problems.
• Build strong working relationships with key customers (project owners) and all validation related functions at site.
• Have full understanding of testing requirements, product & material specifications for both AWC and IC BUs, drawings, and related documentation to ensure compliance.

Qualifications/Education:

• Engineer or similar relevant education (required).
• Lean Six Sigma training (preferred).
• Fluent English, written and oral (required).
• Knowledge of basic requirements of FDA QSR’s GMP’s and ISO 13485 (required).
• Specific software skills – MS Excel, MS Project, MS PowerPoint.

Travel Requirements:

• Position may involve travel worldwide up to 40% of the time. Some trips may include overnight travel.

Working Conditions:

• This role may be based in the Denmark with a hybrid working structure. 

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

#LI-CC1

#LI-Onsite

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!