Lead Tech, Operations

Job Description

A fantastic opportunity has arisen for a Lead Manufacturing Bioprocess Associate.

The Lead Manufacturing Bioprocess Associate provide operational support for shop floor operations of the Late Stage and Launch Pipeline at our new state of the art single use biotechnology facility in Dunboyne.

This role is a site-based role.

The role will be a 24/7 shift role.

Bring energy, knowledge, innovation to carry out the following

The Lead Manufacturing Bioprocess Associate, is responsible for

• Supports end-to end production, supporting production for both Batch and Continuous Manufacturing.

• Operate equipment according to electronic batch records, sampling plans and standard operating procedures.

• Work as part of a dedicated process team where flexibility and teamwork are a key requirement.

• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.

• Support weekend or on-call duty on select time frames to support manufacturing.

• Support the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.

The Lead Manufacturing Bioprocess Associate is also responsible for

• Lead/Guide team members in a process team in one or more unit operations.

• Work with Facility Management/internal team members in the maintaining of GMP status of responsible equipment devices in routine monitoring, calibration, maintenance, and certification.

What skills you will need

In order to excel in this role, you will more than likely have:

• Bachelor’s degree in biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.

• 5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components).

• Competent in troubleshooting and show practical problem-solving capabilities.

• Ability to work independently and within a cross-functional team.

• Understanding of multi column chromatography concepts and Bioreactors

• Familiarity with contamination control and batch release requirements.

• Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.

• Proficiency in various SingleUse techniques and experiences in the area of an end Single Use Facility. Commissioning and Qualification experience.

• Problem, Deviation, and Change Management experience.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills

Bioreactors, Continuous Improvement, DeltaV DCS, Downstream Operations, PAS-X, Troubleshooting, Upstream Operations

Preferred Skills

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

No relocation

VISA Sponsorship

Yes

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

3rd - Night

Valid Driving License

No

Hazardous Material(s)

NA

Job Posting End Date

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.