Connecting to LinkedIn...

Vacancy Details

Engineering & Technical

Senior Manager of Manufacturing - Unknown - 104594

Contract Type: Temporary
Location: Unknown
Date: 6/06/2019
Job Reference: 104594
Contact Name: Deirdre Finnerty
Contact Email:

Job Description

Senior Manager of Manufacturing - Unknown - 104594

Senior Manager of Manufacturing to support Biologics Capacity Expansion. Work closely with a cross functional team including but not limited to Global Pharm Tech, Engineering, Quality, Validations and external Design Team to develop and qualify commercial manufacturing areas to support the Business needs. Initially the role will be heavily involved in the development and qualification of Biologics vial and prefilled syringe processes to ensure the facilities are commercial ready from a Personnel, Quality, Safety and Opex perspectives.

• Recruitment and development of BCE Manufacturing Department
• Develop themselves and their team to become SMEs on biological facility design, aseptics, manufacturing components, primary container closure system, formulations, filling equipment, automation, data integrity, EBR, QRM (CQA’s, CPP’s, CCP’s), cross contamination control, medias strategies.
• Knowledge on all upstream & downstream processes and impact of subprocesses to CQAs, industry complaints, customer, etc…
• High level of input into DFMEA & PFMEAs for facility, equipment and process
• Challenge of Design documentation to meet QA, OPEX and EHS requirements (URS, ES, DS, SDS, HDS, FSDS, RTM, DQ, Pre-FAT, FAT, SAT). Vendor site visits.
• Review, approval & execution of validation activity to meet QA, OPEX and EHS requirements (IQ/OQ/PQ/PPQ)
• Work in conjunction with BCE Trainer on the development of overarching training strategy and roadmap for BCE Operations (Manufacturing)
• Develop and execute clear action plans to ensure Manufacturing Department is ready for commercial launch per EHS, QA and Opex requirements. Development of process flows, SOPs, risk assessments, training processes, batch records, logbooks and necessary documentation to support a commercial manufacturing department

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Education and Experience
• Bachelor’s degree in Science/Engineering or equivalent.
• Minimum 7 years’ experience in the Pharmaceutical/Biopharmaceutical industry
• Knowledge/Experience of working within a clean room manufacturing department
• Proven track record in effective people management to deliver on business goals and objectives
• Good interpersonal and communication skills essential for working across multi-functional teams.

Share this Job

Your Consultant:

Consultant: Deirdre Finnerty
Mobile: 0863073779

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 

Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

Clients we are proud to work with