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Senior Process Engineer – Technical Operations Biotech

Oss, Netherlands

Job Description

Do you have an academic or PhD degree in life sciences, chemical or bioprocess engineering or comparable level through experience and at least 6 years of  experience in a validation role in the pharmaceutical industry? Are you driven to meet project targets and do you have strong project management skills? We would like to get in touch with you for the role of:

Senior Process Engineer – Technical Operations Biotech in Oss

Welcome to our team

CoE Biotech Technical Operations in Oss provides process technological support to the local cell culture and purification facilities and involves 2nd line trouble shooting, process improvement projects and new product introductions. The work in BTO is highly multidisciplinary as it requires close collaboration with manufacturing operations (IPT), analytical laboratories, quality assurance, regulatory affairs and global technical groups (GES). The team consists of approximately 50 members, with expertise in a variety of topics like microbiology, cell culture, purification, engineering, small-scale laboratory operations and process and system validation.

The role as Process Engineer is a critical technical role within Technical Operations, ensuring systems used in the pharmaceutical production of biologics are in line with the GMP regulations. Specifically, he/ she will be responsible for supporting Upstream and Downstream manufacturing and providing expertise in (capital) projects on system design and execution, equipment user requirement specifications and process & facility fit assessments. The Senior Process Engineer is not expected to have direct reports, but could manage temporary Employees.

Primary responsibilities

  • Accountable for implementing the global guidelines and regulatory expectations in systems design (e.g. in URS, FDS, P&ID) and assure alignment with EHS requirements.

  • Acquired knowledge in critical utilities.

  • Accountable for engineering/process calculations for e.g. sizing of equipment and facility fit assessments;
  • Creation and approving of technical life cycle documentation required for qualification of equipment (e.g. IOPQ / pVMP)
  • Be point of contact regarding GMP process systems design (facilities/utilities/equipment) for the Center of Practice - CoP and for the IPTs. E.g. participate in global peer groups and leading meetings with site SMEs.
  • A lead role or participate as SME in Quality Risk Assessments related to design and use of GMP systems.
  • Drive a deep understanding of the importance of compliance, considering an impact on EHS, GMP and regulatory requirements in facility, utility and equipment decisions made.  Having knowledge and understanding of regulatory requirements within European and International codes, standards and practices.
  • Assess process, equipment, utility and/or facility changes for equipment qualification/validation impact.
  • Expected to bring equipment and process design expertise and strong analytical and systematic problem-solving skills, supporting investigation teams in the event of system failures to identify root cause and corrective/preventive actions. And where needed, support the IPTs for the Impact Assessment for equipment deviations.
  • Support IND, IMPD and BLA submissions, by authoring and/or reviewing the facilities utilities and equipment related source documents and/or CMC sections as appropriate.
  • Participate as SME during Pre-Approval Inspections, GMP inspections from Health Authorities and internal audits.
  • Academic degree in life sciences (Biotechnology or related) or comparable level through experience
  • Minimal 8 years’ experience as engineer at a (biologics) pharmaceutical manufacturer
  • Engineering knowledge of pharmaceutical production/purification processes in USP and/or DSP.
  • Demonstrated track-record as lead process engineer in cross functional projects, leveraging both internal and/or external partners; supporting concurrent projects.
  • “Go to Gemba” mentality
  • Knowledge of CGMP guidelines and regulatory expectations
  • Experienced in performing/reporting quality risk assessments (QRA) to support design and use of systems
  • Team player with ability to work in a multidisciplinary setting
  • Strong leadership and collaboration skills within an empowered (project) team setting
  • Must demonstrate personal commitment with respect to inclusion, working safely, healthy and environmentally friendly and all other guidelines.
  • Customer focused, process oriented and data driven
  • Experience with lean problem-solving methodologies for continuous improvement of e.g. costs, quality, process robustness, standardization)
  • Dutch (preferred) and English communication skills, verbally and written.

We Offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

  • Competitive salary and a 3% year-end bonus;
  • 35,5 days of leave;
  • Attractive collective health care insurance package with considerable reduction rates;
  • Solid Pension Plan;
  • Incentive Plan;
  • Travel allowance for commuting;
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID: R279175

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