Validation Manager

Highly Competitive
  1. Permanent
  2. Validation
  3. United States
Boston, Massachusetts
Posting date: 29 May 2019
VA.JE.23567_1559123873

A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Validation Manager. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's Massachusetts office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.

The Validation Manager will proactively lead and manage the Engineering and Validation staff, overseeing Calibration, Maintenance, GMP Facilities, Process Engineering and Industrial Automation, and Lab Computerized System Maintenance activities at the site. They will ensure that qualification, validation, and requalification of equipment, facilities, utilities, and automated systems are carried out in accordance with company procedures and policies, local cGMP, and best industry practices.

Job Responsibilities:

  • Providing effective leadership to resolve complex mechanical/electrical/control issues and to facilitate the investigation and elimination of maintenance process issues to ensure company efficiency and compliance requirements are met.
  • Controlling department budgets via means of monitoring and reporting actual expenditure versus budget.
  • Developing a Predictive & Preventative Maintenance programme to ensure compliance from an EHS and Quality perspective, as well as cost effective from a business perspective.
  • Responsible for Management of Good Engineering Practices program.
  • Providing end user input into all capex projects from a facilities, maintenance, and industrial automation perspective.
  • Managing appropriate KPI's to measure service/performance levels and utilising this to establish a continuous improvement.
  • Ensuring the optimum use of operational excellence tools in all aspects of maintenance department and for ensuring an OE culture exists in all aspects of the maintenance department.
  • Supporting cGMP inspections by health authorities.
  • Leading the preparation, revision, and approval of the site validation master plan (VMP).
  • Delivering on validation timelines relating to Strategic Projects on site.
  • Leading and managing the development of Validation Plans to support the Site Master Plan, as applicable.
  • Assuring site subject matter experts on all validation and qualification activities are appropriately led, managed, and trained at all times.
  • Leading the validation efforts for all Strategic Projects on site.
  • Managing the preparation, review, and/or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, (manufacturing processes), and cleaning processes, as well as providing regulatory guidance and auditing for Quality.
  • Managing the review and approval of third party generated protocols and reports.
  • Managing the review, execution, and approval of site acceptance testing (commissioning) activities.
  • Managing deviations and investigations, as well as other quality systems impacting Quality Validation.
  • Managing change control activities, as appropriate.
  • Performing periodic reviews of systems in order to maintain validation status.
  • Managing the site Validation budget.
  • Supporting cGMP inspections by health authorities.
  • Ensuring compliance with all relevant EHS legal and other legislative requirements and actively promoting and supporting EHS initiatives across the site.
  • Promoting a safety culture within their area and ensuring that plant personnel adhere to safe work practices and to standard operating procedures.
  • Maintaining and continuously improving compliance levels, monitoring GMP and EHS compliance through shop floor presence, and taking appropriate corrective action where needed.
  • Ensuring all accident/incidents are investigated in a timely manner and effective corrective and preventative actions are put in place to prevent re-occurrence.
  • Ensuring the closure of EHS actions raised from accidents/incidents, audits, risk assessments etc., are managed and closed in a timely manner
  • Ensuring risk assessments for the area are carried out, documented, reviewed, and communicated to all relevant personnel in the area.

Skills and Requirements:

  • At least a Bachelor's degree in a relevant field.
  • Demonstrable experience in a similar or relevant role.
  • A thorough understanding of cGMP, validation, engineering, and practices, along with a knowledge of implementation.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joseph Emmott at +44 203 814 1316 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-JE1

#Compliance/Quality

close